CQV Lab Qualification Specialist

Ireland  /  Europe/Ireland  /  Full Time


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.
 
Meeting a Higher Standard:
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 CQV – Lab qualification specialists to join our growing operations in Ireland. The role of a seeking CQV – Lab qualification specialist in CAI is to:
 
·        Support life cycle documentation and execution,
·        Author/Draft validation life cycle documents for review and approval.
·        Route drafted documents for review.
·        Request approval workflows to Doc Control.
·        Route the reviewed documents for workflow approval.
·        Request performance copies for protocols.
·        Execute protocols
·        Review executed protocols.
·        EMRs, movement of equipment.
·        Route drafted documents for review.
·        Request approval workflows to Doc Control.
·        Request performance copies for protocols.
·        Execute approved protocols.
·        Liaise cross-functionally with stakeholders.
 
Position Requirements:
·        BS or MS in a relevant science or engineering field, or equivalent
·        2+ years in CQV roles for life sciences – Lab Qualification experience is essential
·        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-onsite

APPLY FOR THIS JOBALL OPEN POSITIONS

CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country