CQV/Validation Engineer
Posted Updated 4
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Description
About CAI:
CAI is a 100% employee-owned company established in 1996, that has 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.
Are you Ready?
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 a CQV Engineer to join our growing operations in Ireland The role of a CQV Engineer in CAI is to:
· 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, FAT's, 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 -
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable
· 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.
#LI-JD1
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 company. We 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.
As published by lever · 8 questions · 2 written answers
Basics
Which location are you applying for?, Resume/CV, Full name, Pronouns, Email, Phone, Current location, Current company, LinkedIn URL, Twitter URL, GitHub URL, Portfolio URL, Glassdoor URL, What is your age range?, I identify my ethnicity asSelect all that apply, What gender do you identify as?, Are you a U.S. Military Veteran
Short answers (2)
- Please provide earliest commencement date for this role?
- If referred by a CAI employee, please provide their name(s) optional
Pick from a list (4)
- How many years of relevant work experience do you have?
- Do you currently have a valid passport?
- Are you willing to relocate if necessary?
- Regarding travel, how much would you be willing to do? Travel scenarios include, but are not limited to, 10 days on/4 days off rotation, monthly to yearly client site commitments, within and outside of home region, and/or occasional international travel.
Written answers (2)
- What is your salary expectation? (Please provide a numeric value, a range is acceptable)
- What is your current work authorization for various countries/regions? EU, Asia, Australia, US, etc. optional