Navy Nuclear Trained Personnel for Data Center, Building Commissioning and Pharma CQV

April 8, 2020 10:17 pm || Published by

CAI is seeking Navy Nuclear Trained Junior Officers (111X and 112X, 1120 preferred) and Enlisted (MM, ET, EM) looking for their next career.  CAI was founded by Navy Nukes, and approximately 25% of our US team served in the Nuclear Navy before joining CAI.  Success as a Navy Nuke translates to a successful career with CAI.  Join us and put the hard work and training of your Navy days to good use with CAI. We have found that commissioning a ship fits perfectly into commissioning, qualifying and validating Pharmaceutical (BcX), Data Center (DcX) or other mission critical facilities and equipment.   We are 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.   We offer full-time positions 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.   Our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never experienced a lay off. On any given day our teams are responsible for a myriad of activities involved in starting up a facility, equipment or process including QA test document development, third party factory acceptance testing, on site inspections and tests, system 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 time zones, we sometimes travel to our client site for 10 days then return home for 4. Your location is not really critical as long as you're open to travel.    Requirements include:  Nuclear Trained Officers – qualified engineer and submarines Nuclear Trained Enlisted – qualified EWS and submarines 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. 

Commissioning and Qualification Engineer

April 8, 2020 6:42 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

Computer Systems Validation Engineer

April 8, 2020 6:42 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. We use all majors systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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. 

Computer Systems Validation Engineer

April 8, 2020 6:39 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 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 7-10 years’ experience with Computer systems validation in the USA 2 years’ experience working in a GMP environment Experience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 expericence 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, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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. 

Pharmaceutical Project Manager

April 8, 2020 6:39 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. 

Commissioning & Qualification (CQV) Lab Lead/PM

April 8, 2020 6:39 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 a motivated Commissioning Qualification (CQV) Lab Lead/PM 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 Commissioning & Qualification (CQV) Lab Lead/PM will develop and execute documentation according to GAMP 5 guidance for Analytical Laboratory Test Equipment and other Lab Information Systems.   Requirements include:  BS or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline. Ability to qualify any lab equipment from end to end, including PQ (Performance Qualification), methodology and assessment, etc. More than Five (5) years of experience validating laboratory computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems Experience in managing QC Lab startup projects Development and Execution of Computer System Validation (CSV) documentation according to GAMP 5 guidance for Analytical Laboratory Test Equipment and other Lab Information Systems Participate in Data Integrity Gap Analysis discussions. Perform System Lifecycle Documentation updates as required. Provide Computer System Validation (CSV) support for lab-scale manufacturing equipment, systems, and QC instrumentation to ensure compliance with data integrity guidelines and procedures. Perform mitigation and remediation activities as required. Documentation includes, but not limited to: Risk Assessments, Validation Plans, Design Specifications, User Requirements, Functional Requirements, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, and Summary Reports. Development of SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documentation. Initiating and leading change controls for implementation of new instrumentation, equipment and systems. Knowledge on computerized system with data collection software (database). Knowledge with network communications protocol (i.e. TCP/IP) Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations Knowledge of the Empower platform. Knowledge in Project Management and Visio programs. Experienced in Laboratory Instrument Performance qualification, execution and method configuration. Acquainted with GAMP5 methodology for validations. At least three (3) years of experience working with PLC’s, Industrial Computers or laboratory instrumentation systems.  

Commissioning and Qualification Engineer

April 8, 2020 6:39 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

April 8, 2020 6:02 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. 

Commissioning and Qualification Engineer

April 8, 2020 6:02 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 -7 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

Computer Systems Validation Engineer

April 8, 2020 6:02 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 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 7-10 years’ experience with Computer systems validation in the USA 2 years’ experience working in a GMP environment Experience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 expericence 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, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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.