Stiamo ricercando un Junior CSV Engineers con: 1-3 anni di esperienza e almeno un anno di esperienza nel campo delle GMP. Assunzione a tempo indeterminato, è richiesta disponibilità a trasferte.
Position Description:
The Computer Systems Validation (CSV) 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 GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
1-3 years’ experience with Computer systems validation
1 years’ experience working in a GMP environment
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is a plus
Experience in biotech and pharma is preferred over medical device
Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
#LI-AG1
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 Microbiologist – Senior I to join our growing operations in Europe. This role can be based in either Ireland or Italy and will require travel to both countries. The role of a Microbiologist – Senior I in CAI is to:
· Leads execution of instrument and method validations at customer sites
· Participates in customer meetings.
· Inoculates and reads microbiology validation samples.
· Participates in the writing of protocols, reports, and specifications.
· Trains customer on instrument usage and inoculation technique
· Drives deliverables to completion with structured timelines.
Position Requirements:
· Degree in microbiology, biology, or science-related field with a minimum of 3+ years of management related experience in the Pharmaceutical/Life Sciences industry. Relevant experience can substitute for education.
· Understanding of good documentation practices and general quality laboratory function
· Ability to work independently and manage multiple projects simultaneously.
· Strong attention to detail, organizational skills and drive to be successful.
· Experience with aseptic technique and biological safety cabinets
· Outstanding oral and written communication skills (Interpersonal).
· Strong problem-solving abilities for complex problems and ready to take up challenges.
· Strong customer-service focus.
· Willingness and flexibility to travel throughout Europe and potentially internationally if required.
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
4-12 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 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
Position Description:
The Project Manager will provide leadership and management of project teams to successfully deliver scope of work projects in the pharmaceutical manufacturing industry. This person is responsible for identifying and coordinating activities related to a variety of projects including but not limited to construction, commissioning, qualification, IT, engineering, etc. They will be responsible for maintaining budget, building/adhering to a schedule, delegating tasks, communicating effectively, and providing strict scope management. Technical expertise, willingness to complete project tasks, and experience in the pharmaceutical manufacturing industry are highly desired.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent experience
2-4+ years’ experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
Technical experience in one or more practices within the pharmaceutical industry.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or 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 Project Manager will provide leadership and management of project teams to successfully deliver scope of work projects in the pharmaceutical manufacturing industry. This person is responsible for identifying and coordinating activities related to a variety of projects including but not limited to construction, commissioning, qualification, IT, engineering, etc. They will be responsible for maintaining budget, building/adhering to a schedule, delegating tasks, communicating effectively, and providing strict scope management. Technical expertise, willingness to complete project tasks, and experience in the pharmaceutical manufacturing industry are highly desired.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent experience
5-7+ years’ experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
Technical experience in one or more practices within the pharmaceutical industry.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or 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 Validation Process 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 relevant science or engineering field, or equivalent years of hands on experience
4-8 years’ experience performing 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
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and possibly internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or 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 CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 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.
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.
Position Description:
The Computer Systems Validation (CSV) 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 GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
2-7 years’ experience with Computer systems validation
2 years’ experience working in a GMP environment
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
Experience in biotech and pharma is preferred over medical device
Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
La selezione rispetta il principio delle pari opportunità (l. 903/77)
#LI-AG1
Duties
Provide project oversight for deployment of SAAS platforms within a GMP environment;
Manage IT projects, their cost, scope, and timelines;
Collating user requirements from impacted functional groups;
Managing and collating stakeholder expectations;
Key interface between Cell Therapies Pty Ltd and engaged platform providers;
Ownership of project schedules and generation of status reports;
Presentation of project progress to the Cell Therapies Leadership team as required.
Skills & Experience
Previous experience in deploying software of IT systems within a GMP regulated industry;
Experienced in deploying EBR, MES, SCADA, LIMS or eQMS large scale automation systems;
Excellent understanding of GAMP requirements;
Advanced communication and negotiating skills;
Demonstrated experience in leading cross functional teams and building collaborative relationships;
Excellent stakeholder management and negotiation skills;
Critical thinking and problem-solving skills.
Essential
Highly effective communicator;
Demonstrated ability to influence at all levels of the business;
A diligent and quality-driven approach;
Ability to multitask and work autonomously as well as in teams
#LI-KO1
About CAI:
CAI was established in 1996, it has grown year over year to more than 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.
At 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.
We strongly believe that 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.
The role:
The Electrical Commissioning Engineer Lead provides direction of all electrical aspects of assigned commissioning projects from initial engagement through turn over to the client. He/she will be expected to execute against the project schedule through the coordination of contractors and/or vendors to complete the desired electrical system testing while ensuring the safety of oneself and other project personnel.
Responsibilities:
· Lead and steer all electrical commissioning and testing activities for all contracted testing and commissioning work related to electrical systems at the client`s site according to agreed Scope of Works.
· Act as technical expert and advisory for the client, advising on feasibility, practicality and any cost, resource impact of solution, methods and work procedures at all stages of the commissioning process.
· Fulfil the role of on-site technical lead and coordinate obtaining correct information from equipment vendors, client, contactors and site owners to make decision and lead.
· Participate and contribute to meetings with the client, consultants, other contractors to provide expert technical opinion. Work with all commissioning stakeholders to sign-off and commit to a common and agreed commissioning deliverables scope and outline items.
· Ensuring all relevant certification and required documentation have been provided by construction contractors, equipment/system vendors to be approved and used as reference for commissioning documentation development.
· Review, check, analyze, and provide opinion on design documents such as BoD, OPR, electrical drawings, schematics, diagrams and installation drawings as well as approve documents meeting commissioning requirements of the client.
· Support engineering and commissioning deliverables development, working together with team members
· Develop, create, review and achieve approval of test scripts, Inspection Test Plans (ITPs)
· Develop, create, review, achieve approval and initiate Factory Acceptance Tests (FAT) or Factory Witness Tests (FWT)according to the needs of the client
· Ensure delivery quality is consistent with testing and commissioning requirement from client and the tested outcome is consistent with the client`s desired specification and performance requirements
· Enforce and work to the client`s project timelines and supervise electrical commissioning activities according to the client`s commissioning schedule and timeline
· Manage the progress of work through task completion progress tracking and regular work completion status updates. Pro-actively and regularly update, provide feedback and communicate on work progress with internal teams, Project Manager and client team on work progress
· Create and develop regular technical reports regarding commissioning project status
· Using expert knowledge to identify and create an informed opinion, clearly and transparently communicate to the Project Manager, Client Manager on issues, opportunities, challenges or risks to project schedule and resourcing during any stage of work
· Track potential changes during job progression and have competency in understanding identifying scope variation (potential scope and requirement changes) and how it affects commissioning schedule, budgeting and initially defined commissioning targets
· Collaborate closely with Project Manager when quantifying any scope variation including any price, budget or resource change and to assist in developing mitigation or contingency plans.
Critical Skills and Knowledge
· Bachelor degree or equivalent experience
· Knowledge of OSHA (or equivalent) safety requirements.
· Good written and spoken communication skills.
· Ability to read and interpret electrical schematics and mechanical P&IDs.
· Knowledge of mission critical design concepts.
· Knowledge of Electrical Distribution Switchgear, Substations, Uninterruptable Power Sources (UPS), Automatic Transfer Switches (ATS), Batteries, Emergency Diesel Generators & Load Banks.
· Knowledge of power quality analysis
Working Environment:
Extensive travel (75%)
Construction environment
#LI-KO1
About CAI:
CAI was established in 1996, it has grown year over year to more than 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.
At 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.
We strongly believe that 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.
This Mechanical Engineer Lead performs mechanical systems testing in compliance with a project schedule. The mechanical engineer should have a working knowledge of mechanical P&IDs, electrical one-line drawings and a general understanding of mechanical systems: Mechanical (HVAC) systems, air distribution (fans, ducting, VAVs), refrigeration systems, chilled water systems, hot water heating systems, steam heating systems and fire protection equipment. He/she will drive the functional performance test for each mechanical system assigned and is expected to be able to competently follow approved test scripts. Needs to be self-motivated and willing to actively engage contractors/vendors to set up testing to complete all required activities for project success
The witness, verification and validation of proper execution of commissioning tests is to be documented by the Mechanical Engineer Lead. The quality of documentation is vital to success of program and the Mechanical Engineer Lead is expected to have knowledge and ability to complete all document requirements and ability to lead project independently.
Responsibilities
· Lead and steer all mechanical commissioning and testing activities for all contracted testing and commissioning work related to mechanical, cooling, HVAC, airflow, water, refrigerant/return piping and plumbing systems (and possibly structural and civil expertise) at the client`s site according to agreed Scope of Works
· Guide technical discussion and clarification with client acting as and advisor/coordinator for any technical, mechanical, cooling, HVAC, airflow, water, refrigerant/return piping and plumbing related topics and in some circumstances structural and civil engineering related topics
· Act as technical expert and advisory for the client, advising on feasibility, practicality and any cost, resource impact of solution, methods and work procedures at all stages of the commissioning process
· Fulfil the role of on-site technical lead and coordinate obtaining correct information from equipment vendors, client, contactors and site owners to make decision and lead
· Participate and contribute to meetings with the client, consultants, other contractors to provide expert technical opinion. Work with all commissioning stakeholders to sign-off and commit to a common and agreed commissioning deliverables scope and outline items
· Ensuring all relevant certification and required documentation have been provided by construction contractors, equipment/system vendors to be approved and used as reference for commissioning documentation development
· Review, check, analyze, and provide opinion on design documents such as BoD, OPR, mechanical, cooling, HVAC, ducting, piping and plumbing drawings, schematics, diagrams and installation drawings as well as approve documents meeting commissioning requirements of the client
· Support engineering and commissioning deliverables development, working together with team members
· Develop, create, review and achieve approval of test scripts, Inspection Test Plans (ITPs)
· Develop, create, review, achieve approval and initiate Factory Acceptance Tests (FAT) or Factory Witness Tests (FWT)according to the needs of the client
· Ensure delivery quality is consistent with testing and commissioning requirement from client and the tested outcome is consistent with the client`s desired specification and performance requirements
· Enforce and work to the client`s project timelines and supervise all mechanical, cooling, ducting, piping and flow/balancing commissioning activities according to the client`s commissioning schedule and timeline
· Steer and guide all stakeholders (general contractors, equipment suppliers, BEP contractors) to achieve commissioning outcomes to the prerequisites of the client BoD and OPR, periodically assessing and evaluating the conformance, progress and suitability of planned work in line with the agreed commissioning deliverables
· Supervising, monitoring all mechanical, cooling, airflow, piping and plumbing commissioning works ensuring the tests are effective for all associated Cx levels
· Facilitating effective handover of equipment, facilities and outcomes from commissioning, ensuring all required certification and associated records, testing/verification documentation have been checked and approved and signed-off from vendors, construction contractors as well as by the company for test performance confirmation
· Check that critical decisions, actions and planning regarding commissioning are shared, reviewed and developed together with the company's global expertise to ensure consistency with the company`s global approach and policy, standards
Critical Skills and Knowledge
· Bachelor degree or equivalent experience
· Knowledge of OSHA safety requirements.
· Good written and spoken communication skills.
· Ability to read and interpret electrical schematics and mechanical P&IDs.
· Knowledge of mission critical design concepts.
· Knowledge of various Building Automation/Monitoring Systems (BAS/BMS), Air Handlers, Humidifiers, Variable Refrigerant Flow, Computer Room Air Conditioners/Handlers (CRAC/CRAH), Evaporators, Adiabatic Coolers, Pressure/Temperature/Humidity sensors & Flowmeters.
· Knowledge of basic thermodynamics and heat transfer and fluid flow.
· Knowledge of the Test, Adjust and Balance (TAB) process.
· Knowledge of mechanical trend analysis.
· Strong experience with Word, Excel and PowerPoint.
Working Conditions
· Extensive travel may be required (75%)
· Work under construction site conditions
#LI-KO1
“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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