Commissioning and Qualification Engineer

July 22, 2019 11:28 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 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

Pharmaceutical Project Manager

July 22, 2019 11:27 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 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. 

Data Center Building and Commissioning Lead, North America

July 22, 2019 11:11 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 Data Center Commissioning Discipline Leads 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.   This Data Center Commissioning Discipline Lead will be: Active in creating industry-changing approaches, ideas, etc., and helping clients and the broader industry implement these changes. Active selling our services and providing strategic project work. Involved in professional societies, standards-setting committees, government-industry collaborations, authoring white papers and articles, public speaking, training. Able to generate their own work based on their network of industry contacts, and to provide project work to others in their discipline. Expected to support industry and business development roles outlined above.   The Data Center Commissioning Discipline Lead will support the DC Business area by: Developing the DC quality system, knowledge management repository and services delivery definition Contributing to the development of DC capability   Providing timely and relevant industry and subject information to the company through internal distribution channels, deliver internal training, and contribute to our store of knowledge.   Requirements include: BS in a science or engineering field or equivalent years’ experience 10 years or more of experience in DC commissioning or facility engineering / facility management Experience in 1 or more of the following: design reviews, facilities and equipment startup walk downs & troubleshooting, HVAC, Medium/ Low voltage, LEED, facility auditing, DC infrastructure, and Back-up/ UPS systems Excellent oral and written communication skills in English  Able to travel domestically and internationally  Able to work overtime  Able to work in the US without sponsorship now or any time or in the future. 

Building and Commissioning Engineer

July 22, 2019 11:11 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 Facility Engineers and  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.   Facility Engineers will act as contracted resources in support of our manufacturing clients’ facility and engineering departments, and be responsible for commissioning, start-up, and developing maintenance programs and plans. Building commissioning professionals develop and execute the commissioning tests to demonstrate to the customer that vendor building, and facility are correctly installed and set to work, support enhanced design reviews, and consult on submission of LEED qualification packages. Requirements include: BS in a science or engineering field or equivalent years’ experience 0-3 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: facilities and equipment startup walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery or other pharmaceutical manufacturing processes 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.  Able to work in the US without sponsorship now or any time or in the future. 

Commissioning and Qualification Engineer

July 22, 2019 11:11 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 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

Pharmaceutical Project Manager

July 22, 2019 11:11 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 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 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.  Aseptic manufacturing experience is highly desired.   Requirements include:  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. Experience with developing user requirements, design specifications, process/product risk assessments, validation requirements, development of testing protocols and test plans, and overall experience with the validation life-cycle is required. Experience with CIP/SIP, and aseptic manufacturing 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. 

Validation Engineer w/ Aseptic Filling

July 22, 2019 5:20 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 Validation Engineers with Aseptic Filling experience 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 Validation Engineer will develop and execute protocols and test scripts.  This person is responsible for writing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports.    Requirements include:  BS in a science or engineering filed or equivalent experience Experience with Aseptic Filling equipment and processes in a GMP environment Experience with risk assessments, qualification protocols, commissioning plans/test scripts and summary reports 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 in the future. 

Validation Engineer

July 22, 2019 5:20 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 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 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 Validation Engineer will develop and execute protocols and test scripts.  This person is responsible for writing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports.    Requirements include:  BS in a Computer Science or Engineering field or equivalent experience (such as the Navy Nuclear Power program, pharmaceutical process engineering, or civilian and military aviation maintenance) 1-6 years' experience with GMP Commissioning and Validation is preferred Experience with biotech-fermentation, recovery or purification processes and systems is a plus. Experience with managing a small to medium validation project is a plus Conversant with MS Word and Excel, especially MS Word Styles and formatting 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 in the future. 

Computer Systems Validation Engineer

July 22, 2019 5:20 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 Computer System Validation (CSV) 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 Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. 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.   Requirements include:  BS in a Computer Science or Engineering field or equivalent experience 4 years’ experience with Computer systems validation in the USA 2 years’ experience working in a GMP environment Experience with GAMP is highly desired Experience in biotech and pharma is preferred over medical device Experience with MES, Delta V, PI is a plus 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. 

Commissioning and Qualification Engineer

July 22, 2019 5:20 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 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