Commissioning and Qualification Engineer

September 23, 2019 10:32 am || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries. CAI will be at the Boston ISPE Product Show, Wednesday, September 18th @ Gillette Stadium in Foxborough, MA - please stop by and see us! We'll have hiring managers and Recruiting staff on hand at booth w74 and the career fair. CAI is seeking motivated CQV Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   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:  BS in a science or engineering field or equivalent years of experience 3 years' experience in commissioning and qualification 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 Excellent oral and written English is required 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

Commissioning and Qualification Engineer

September 23, 2019 9:00 am || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI is seeking motivated CQV Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   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:  BS in a science or engineering field or equivalent years of experience 3 years' experience in commissioning and qualification 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 Excellent oral and written English is required 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

Bio Manufacturing Process & Validation Engineers

September 23, 2019 7:17 am || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, design and other consulting services to FDA regulated and mission critical industries. CAI will be at the Boston ISPE Product Show, Wednesday, September 18th @ Gillette Stadium in Foxborough, MA - please stop by and see us! We will have Hiring Managers and recruiting staff on hand at booth w74 and the career fair!   CAI is seeking motivated biomanufacturing process engineers and biomanufacturing validation engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to numerous types of industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a consistently growing company.              Travel is required to achieve full success for the agents and the clients we serve.  Most travel occurs within the US, but international travel can be also be requested as interested.  Please check CAI out on Glassdoor to get a better perspective on our culture and travel. We are extremely proud that our employee owners have given us so many 5 star ratings.   Position Requirements:  BS or MS in a relevant engineering or science field, or equivalent experience Excellent oral and written communication skills in English Team-oriented Customer-service focused Able to travel domestically and internationally if required Able to work (paid) overtime as needed Able to work in the US without sponsorship now or any time in the future   Process Engineering Experience: Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of: Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing Single use biomanufacturing systems Continuous Process Verification (CPV) (using Minitab or other statistical software) Process performance qualification (PPQ) Deviation and CAPA investigations Experience with biomanufacturing processes: Cell culture, expansion, harvest, purification, formulation, fill and finish Blood plasma fractionation and component purification Cell and gene therapy     Other Desired Experience: Commissioning and Qualification Developing Validation / Verification Master Plans Performing formal risk assessments / FMEA Identifying Critical Attributes and Critical Process Parameters Developing User Requirements Writing qualification protocols, commissioning plans/test scripts, and summary reports Developing trace-ability matrices Project Management Project planning and estimating Schedule development and execution Issue tracking and resolution Establishing metrics and leading team to achieve performance goals Facilitating meetings

Aseptic Process & Validation Engineers

September 23, 2019 7:17 am || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, design and other consulting services to FDA regulated and mission critical industries.   CAI is seeking motivated: ·        Aseptic Process Engineers and Aseptic Validation Engineers   to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to numerous types of industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a consistently growing company.              Travel is required to achieve full success for the agents and the clients we serve.  Most travel occurs within the US, but international travel can be also be requested as interested.  Please check CAI out on Glassdoor to get a better perspective on our culture and travel. We are extremely proud that our employee owners have given us so many 5 star ratings.   Position Requirements:  ·        BS or MS in a relevant engineering or science field, or equivalent experience ·        Excellent oral and written communication skills in English ·        Team-oriented ·        Customer-service focused ·        Able to travel domestically and internationally if required ·        Able to work (paid) overtime as needed ·        Able to work in the US without sponsorship now or any time in the future     Aseptic Process Engineering Experience:   ·        Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of: o   cGMP manufacturing process activities within isolators or biosafety cabinets (e.g. Cell and Gene Therapy) o   Sterile Operations - Vial/prefilled syringe/cartridge filling lines o   Lyophilization/freeze drying o   Automated visual inspection systems o   Automated formulation systems o   Autoclaves o   CIP/SIP   Other Desired Experience:   ·        Commissioning and Qualification o   Developing Validation / Verification Master Plans o   Performing formal risk assessments / FMEA o   Identifying Critical Attributes and Critical Process Parameters o   Developing User Requirements o   Writing qualification protocols, commissioning plans/test scripts, and summary reports o   Developing tracability matrices   ·        Project Management o   Project planning and estimating o   Schedule development and execution o   Issue tracking and resolution o   Establishing metrics and leading team to achieve performance goals o   Facilitating meetings

Aseptic Process & Validation Engineers

September 23, 2019 7:17 am || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, design and other consulting services to FDA regulated and mission critical industries. CAI will be at the Boston ISPE Product Show, Wednesday, September 18th @ Gillette Stadium in Foxborough, MA - please stop by and see us! We'll have Hiring Managers and Recruiting staff on hand at booth w74 and the career fair.   CAI is seeking motivated Aseptic Process Engineers and Aseptic Validation Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to numerous types of industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a consistently growing company.              Travel is required to achieve full success for the agents and the clients we serve.  Most travel occurs within the US, but international travel can be also be requested as interested.  Please check CAI out on Glassdoor to get a better perspective on our culture and travel. We are extremely proud that our employee owners have given us so many 5 star ratings.   Position Requirements:  BS or MS in a relevant engineering or science field, or equivalent experience Excellent oral and written communication skills in English Team-oriented Customer-service focused Able to travel domestically and internationally if required Able to work (paid) overtime as needed Able to work in the US without sponsorship now or any time in the future   Aseptic Process Engineering Experience:  Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of: cGMP manufacturing process activities within isolators or biosafety cabinets (e.g. Cell and Gene Therapy Sterile Operations - Vial/prefilled syringe/cartridge filling lines Lyophilization/freeze drying Automated visual inspection systems Automated formulation systems Autoclaves CIP/SIP Other Desired Experience: Commissioning and Qualification Developing Validation / Verification Master Plans Performing formal risk assessments / FMEA Identifying Critical Attributes and Critical Process Parameters Developing User Requirements Writing qualification protocols, commissioning plans/test scripts, and summary reports Developing trace-ability matrices Project Management Project planning and estimating Schedule development and execution Issue tracking and resolution

Data Center Commissioning Mechanical Lead (Any US City)

September 22, 2019 7:30 pm || Published by

CAI, a 100% employee-owned company established in 1996, has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, and other consulting services to FDA regulated and other mission critical industries.   CAI is seeking motivated Building Commissioning/Data Center Mechanical Lead professionals to support data center projects around the world. These are project-based opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol and test script writing and execution, FAT's, SAT's, walk downs, burn in tests and development of summary reports at the client site.    This position requires extensive to full time international travel. Lead Mechanical Engineers will work as part of the CAI data center/ building commissioning team and be responsible for commissioning, safe work practices, facility turnover, and issue resolution. Data Centre/ building commissioning professionals develop and execute the commissioning tests to demonstrate to the customer that vendor equipment is correctly installed and set to work, support enhanced design reviews, and consult on submission of LEED qualification packages. Requirements include: BS in a mechanical or engineering field or equivalent years’ experience 3 years or more of experience in commissioning and qualification in a regulated industry, or facility engineering / facility management Experience in 1 or more of the following: Industrial HVAC and CRAC systems, equipment inspections, industrial cooling, chillers, and water system equipment commissioning, LEED commissioning, Factory Witness Test attendances, leading commissioning processes, or equipment/ facility handover. Excellent oral and written communication skills in English and Spanish  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. 

Data Center Commissioning Electrical Lead (Any US City)

September 22, 2019 7:30 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries. CAI is seeking motivated Building Commissioning/Data Center Electrical Lead professionals to support data center projects across the country. These are full-time opportunities with 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. As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol and test script writing and execution, SAT's, walk downs, FATs, burn in tests and development of summary reports at the client site.  To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to. Lead Electrical Engineers will work as part of the CAI data center/ building commissioning team and be responsible for commissioning, safe electrical work practices, facility turnover, and issue resolution. Data Centre/ building commissioning professionals develop and execute the commissioning tests to demonstrate to the customer that vendor equipment is correctly installed and set to work, support enhanced design reviews, and consult on submission of LEED qualification packages. Requirements include: BS in an electrical or engineering field or equivalent years’ experience 3 years or more of experience in commissioning and qualification in a regulated industry, or facility engineering / facility management Experience in 1 or more of the following: electrical switching operations, equipment inspections, Low and/or Medium voltage equipment commissioning, LEED commissioning, Factory Witness Test attendances, leading electrical commissioning processes, or equipment/ facility handover. 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. 

Data Center Commissioning Project Manager (Any US City)

September 22, 2019 7:30 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI are seeking motivated Building & Commissioning Project Managers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The Project Manager will work with project teams at client sites to inspect, test, and troubleshoot data center/ building commissioning facilities and/ or equipment. This person is responsible for identifying and coordinating activities for commissioning and creating engineering and qualification protocols and reports.  They will also manage the resources (people and budget) for same.  The Project Manager will interact with client (data center/ building commissioning companies) personnel and the Regional Manager.  The Project Manager will execute the work as well as oversee it. Electrical and/ or Mechanical commissioning experience is highly desired.   Requirements include:  BS in an electrical, mechanical, engineering field or equivalent experience 5 years or more of experience in commissioning and qualification in a regulated industry, or facility engineering / facility management Experience with risk assessments, qualification protocols, commissioning plans/test scripts and summary reports is desired Experience managing multi-disciplinary teams with full commissioning responsibility is desired 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. 

Pharmaceutical Project Manager

September 22, 2019 6:46 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries. CAI will be at the Boston ISPE Product Show, Wednesday, September 18th @ Gillette Stadium in Foxborough, MA - please stop by and see us! We will have Hiring Managers and recruiting staff on hand at booth w74 and the career fair.   CAI is seeking motivated Pharmaceutical Project Manager to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The Project Manager work with project teams at client sites to inspect, test, and troubleshoot bio-pharma manufacturing, packaging, and utility systems and equipment.  This person is responsible for identifying and coordinating activities for commissioning and qualification and creating engineering and qualification protocols and reports.  They will also manage the resources (people and budget) for same.  The Project Manager will interact with client (Bio-pharma companies) personnel and the Regional Manager.  The Project Manager will execute the work as well as oversee it.    Requirements Include: BS in a science or engineering field or equivalent experience 10+ 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 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. 

Recruiter

September 22, 2019 1:35 pm || Published by

CAI is a constantly growing organization, having gone from 2 to 500 people since our inception. Recruiting is the lifeblood of our organization as people are our business. In this role you will be working 100% remote unless you’re traveling to company, industry or recruiting functions, so we need a good level of self-motivation, maturity and personal integrity. You will directly support our hiring managers across North America and Puerto Rico and once on-boarded will be fairly autonomous under the mentorship of our senior talent acquisition staff. Individuals with experience recruiting in Pharmaceutical Engineering , Data Center Commissioning /Construction or Building Commissioning (DcX/BcX) will be given priority Recruiter Job Responsibilities: Achieves staffing objectives by recruiting and evaluating job candidates; advising managers Establishes recruiting requirements by studying organization plans and objectives and meeting with managers to discuss needs Builds applicant sources through proactive sourcing and building relationships with industry groups, colleges, competitors and referrals Attracts active applicants by placing job postings on various job sites, using social media, etc. and passive candidates through heavy headhunting Evaluates applicants by discussing job requirements and cultural fit Avoids legal challenges by understanding current legislation, enforcing regulations with managers, recommending new procedures when needed Stays current by participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations. Recruiter Qualifications/Skills: Recruiting and interviewing skills Phone, Skype, and online meeting platform skills Supports workplace diversity Familiarity with relevant employment Law Professionalism, organization, and project management skills 3-6 years exempt and non-exempt recruiting experience in full life-cycle environment, including management of multiple high-volume roles simultaneously Minimum 2 years’ experience recruiting in relevant industry environment When you apply please do not leave compensation blank. Research our benefits thoroughly and tell us what compensation you are expecting Able to work in the US as an FTE without sponsorship of any kind now or in the future