Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
2-4 years' experience in commissioning and/or qualification activities in a regulated industry
Ideally, you'll already have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-8 years' experience in commissioning and qualification in a regulated industry
Ideally experienced in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Excellent technical problem-solving and troubleshooting skills
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while supporting other team members
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs.
Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site. Other responsibilities include planning/coordinating work and directing small teams in document development and/or execution.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-8 years' experience in commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
We are seeking CQV Engineers with 2-4 years' experience and we can assist with relocation costs.
Position Description:
The Commissioning, Qualification and Validation (CQV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing commissioning and qualification documentation such as User Requirements, Design Qualification, commissioning and qualification test cases and protocols, and summary reports.
Requirements include:
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent
2-4 years' experience with commissioning, qualification and/or validation preferred
Experience with manufacturing process equipment—specifically filling, packaging and/or inspection equipment.
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Customer-service focused
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Senior CQV Project Manager to join our growing operations in Europe. The role of a Senior CQV PM in CAI is to:
· Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
· Managing mid-sized to large projects related to process equipment and clean utilities including start-up and commissioning
· Lead design review, site acceptance and installation of equipment
· Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans
· Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
· Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
· Allocate project resources for efficient execution of project deliverables.
· Deliver the C&Q activities as required to meet the schedule
· Track progress of C&Q activities as required.
· Coordinate support during C&Q execution
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 8 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of EU and global regulatory requirements. Proficient in cGMP standards.
· Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
· Skilled at planning and tracking project activities and schedules
· Excellent interpersonal skills to form strong relationships with internal and external clients
· Excellent oral and written communication skills
· Excellent problem-solving skills
· Customer-service focused.
· Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Able to travel domestically and internationally if required.
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We now have an immediate requirement for multiple C&Q roles within the Utilities suite team on one of our largest client sites. The candidates should be self-motivated team players with the ability to own and deliver tasks against schedule-based project deliverables. The ability to adapt to different project challenges is key. The ideal applicant must have 5+ years’ experience in the Commissioning of Black and/or Clean Utility systems within GMP facilities. A degree in Building Services, Mechanical Engineering or related discipline is preferable. This is a site-based role during the C&Q phase with opportunity to work remotely when the project allows. Requirements include:
· Review and approval of C&Q documents,
· Review and approval of CTOP’s and VTOP’s,
· Generation of C&Q documents through electronic validation systems (Kneat or similar),
· Digital C&Q test execution,
· Witnessing of vendor commissioning activities,
· Ownership of Utility systems throughout C&Q phase,
· Reporting daily on C&Q progress,
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 5+ years in CQV Utilities experience within the life sciences industry
· Excellent oral and written communication skills
· Excellent problem-solving skills
· Customer-service focused.
· Able to travel domestically and internationally if required.
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a CQV Engineer to join our growing operations in Ireland The role of a CQV Engineer in CAI is to:
· Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety.
· Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
· Generating C&Q Procedures for projects.
· Approval of TOPs.
· Facilitate scoping / planning of commissioning spares and consumables.
· Deliver the C&Q activities as required to meet the schedule
· Track progress of C&Q activities as required.
· Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM)
· Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
· Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
· Coordinate with project contractors and equipment vendors to execute required tests.
· Allocate project resources for efficient execution of project deliverables.
· Coordinate support during C&Q execution -
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable
· Excellent oral and written communication skills
· Excellent problem-solving skills
· Customer-service focused.
· Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Able to travel domestically and internationally if required.
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Qualified Person (QP) to join our growing operations in Ireland. The role of a QP in CAI is to:
· The Qualified Person is responsible for certifying medicinal products in accordance with requirements of product marketing authorisation, EU Directives, EU Annex 16 and Annex 13 where applicable for Investigational Medicinal Products.
· Provide quality and compliance guidance on critical and major quality matters.
· Provide quality direction and guidance for projects related to processes, product and compliance
· Provide quality oversight of quality management system, procedures, release and compliance documents including CAPAs (Corrective and Preventive Action), Deviation Management, Change Controls and Quality Agreements.
· Ensure all necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitably authorized staff.
· Ensure independence of the QP (Qualified Person) on decisions on quality related matters.
· Provide support with investigations and resolution of discrepancies.
· Provide audit support as required for client Health Authority Inspections, internal auditing program and supplier audits.
· Support client in continuous improvement initiatives for GMP compliance.
· Participate in cross functional teams to provide consultative support on quality related issues.
· Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice
· Supporting Quality / Compliance / Regulatory (QCR) CAI business area lead (BAL) with the achievement of Objectives and Key Results (OKRs).
Position Requirements:
· Third level qualification in a science related discipline
· Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
· Minimum 3 to 5 years QP experience
· Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach.
· Extensive demonstrated pharmaceutical quality experience.
· Must have thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
· Audit experience would be beneficial.
· Must have strong task management skills with the ability to prioritise, schedule, and control under tight deadlines.
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Quality Specialist to join our growing operations in Europe. The role of a Quality Specialist in CAI is to:
· Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations / Environmental Monitoring etc.
· Performs Batch Disposition preparation, Batch record review, Certification process oversight.
· Strong cGMP and regulatory requirement understanding.
· Experience in SAP release, SAP deviation system and Trackwise.
· Support all quality and compliance requirements for and leading to commercial manufacturing.
· Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
· Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
· Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
· Ensure the highest Quality, Compliance and Safety standards
· Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
Position Requirements:
· 5+ years' experience within GMP regulated facilities
· Proven track record in Quality and Compliance.
· Professional Quality Assurance Accreditation desirable
· Bachelor’s degree in a science or equivalent discipline
· Experience with Aseptic manufacture desirable
· Experience of batch record review and product release essential
· Excellent oral and written communication skills in English
Position Description:
Our project managers are technical leads first, with a strong background in CQV strategy, development, and field execution. We look for culture fit above all – our people are our most important asset, and great people make great teams! Our ideal project manager will have experience managing projects of $1m or more, and have managed teams of at least 6-8 engineers and consultants on defined scopes of work.
A successful CAI PM will need to show direct responsibility for scope/schedule/budget for project experience. We love experienced generalists, but if you’re a CQV SME in facilities, clean utilities, upstream and downstream biotech equipment, single use disposable, or aseptic fill finish manufacturing, we’d like to talk to you! A PMP is great, but you’ll need the experience if you want to run with a CAI team. On any given day, you might be leading a budget review meeting, leading a daily huddle with your team, reviewing a summary report, writing a protocol, or supporting your team executing in the field. CAI PMs are active, multifaceted roles - desktop PMs need not apply! The CAI project manager typically reports to either a client manager or an area manager.
Requirements include:
Requirements Include:
BS in a science or engineering field or equivalent experience
4-8 years’ Experience commissioning and qualifying bio-pharma systems equipment and systems
Experience with risk assessments, qualification protocols, commissioning plans/test scripts and summary reports is desired Experience with CIP/SIP is desired
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Proficient and experienced with various Project Management software tools
Customer-service focused
Three (3) or more years serving as a program or project manager for life science projects with budgets of $1MM+. Demonstrated success in leading your team to achieve defined goals. Similar experience in industries other than life sciences will be considered.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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