CQV Engineer

Job Location:

Limerick, PA - USA

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

About CAI:

CAI was established in 1996 we have grown year over year to nearly 700 people worldwide. We provide commissioning qualification validation start-up project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Meeting a Higher Standard:

Our approach is simple; we put the clients 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.

CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognised 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.

Responsibilities include:

We are now seeking a CQV Engineer to join our growing operations in Ireland

Conduct and lead Commissioning Qualification Validation team activities with a direct regard for Safety.

Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.

Generating C&Q Procedures for projects.

Approval of TOPs.

Facilitate scoping / planning of commissioning spares and consumables.

Deliver the C&Q activities as required to meet the schedule

Track progress of C&Q activities as required.

Preparation of Qualification Summary Reports (QSR) and management of Requirement Traceability Matrix (RTM)

Execution of Design reviews shakedown commissioning FATs IQ OQ PQ activities.

Management of any aspect of C & Q verification as requested i.e. Change Controls Management of Contractors and Vendors document control punch list management.

Coordinate with project contractors and equipment vendors to execute required tests.

Allocate project resources for efficient execution of project deliverables.

Coordinate support during C&Q execution -

Requirements:

BS or MS in a relevant science or engineering field or equivalent

3 years in CQV SME roles for life sciences

Excellent oral and written communication skills

Excellent problem-solving skills

Customer-service focused.

Proficient in life science manufacturing processes in areas such as biotech aseptic fill/finish OSD Gene Therapy or equivalent experience.

Able to travel domestically and internationally if required.

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global pledge that CAI will be operated in a way that is fair and equitable to all our employees our customers and the broader society. This job description is not all inclusive and you may be asked to do other duties.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

About CAI:CAI was established in 1996 we have grown year over year to nearly 700 people worldwide. We provide commissioning qualification validation start-up project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.Meeting a H...