POSITION SUMMARY:
We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The Senior CQV Engineer is responsible for
ensuring systems, facilities, and equipment meet design requirements to be put
in place for a facility. The incumbent is also responsible and accountable for
the execution of the PSC mission, “to maintain the integrity and
professionalism of our products and services while enabling steady growth and
development.”
- Act as a
lead and simplify CQV functions, reports, and processes. - Support
implementing safety programs for major capital projects. - Commission,
qualify, and validate facilities, utilities, and/or equipment in assigned
projects. - Initiates,
authors, revises, reviews, and completes controlled documents for CQV projects. - Review
and qualify equipment for commissioning, qualification, and validation
activities. - Writes
and reviews GMP and GDP documents and technical specifications. - Collaborate
with multiple departments on assigned project activities and deliverables. - Initiate
and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ, - Contact
and work with contractors and vendors on assigned projects. - Ability
to travel as needed. - Additional
duties and responsibilities may be assigned from time-to-time.
Requirements
- Bachelor’s Degree in Engineering
or Life Science. - 7-10 years of applicable work
experience in the biomedical and pharmaceuticals industry. - Proficient in authoring and
executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents. - Proficient in developing SOPS,
final reports and validation & quality policies. - Strong experience developing and
executing CQV protocols. - Strong experience creating and
maintaining CQV policies and processes. - Has good understanding and
complies to cGMPs and CFR21 Part 11 guidelines. - Demonstrated strategic thinking
and implementation skills; proven analytical skills with ability to translate.
Data to actionable plans; demonstrated ability to develop and implement
marketing and product/service. strategies by converting them into tactical
marketing plans; execute and deliver results. - Excellent presentation and
communication skills, written and oral, for a variety of audiences. - Highly organized in planning and
time management, with the ability to multi-task.