CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 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.
We are now seeking a Senior CQV Project Manager to join our growing operations in Ireland. The role of a Senior CQV PM in CAI is to:
· Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
· Managing mid-sized to large projects related to process equipment and clean utilities including start-up and commissioning
· Lead design review, site acceptance and installation of equipment
· Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans
· Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
· Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
· Allocate project resources for efficient execution of project deliverables.
· Deliver the C&Q activities as required to meet the schedule
· Track progress of C&Q activities as required.
· Coordinate support during C&Q execution
· BS or MS in a relevant science or engineering field, or equivalent
· 8 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of EU and global regulatory requirements. Proficient in cGMP standards.
· Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
· Skilled at planning and tracking project activities and schedules
· Excellent interpersonal skills to form strong relationships with internal and external clients
· 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.