CQV Project Manager
Swiftwater, PA 19428
The CQV Project Manager will provide CQV project management to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.
This position is client facing with an emphasis on ensuring CQV project deliverables meet schedule, cost, scope, quality, and safety.
Will develop CQV planning documents to manage CQV projects
Perform risk assessments and impact assessments
Lead the team in generating and executing CQV protocols using Good Documentation Practices (GDPs)
Lead the team in Investigating and resolving protocol exceptions or discrepancies
Lead the team in developing technical reports and CQV summary reports
Lead the team in startup of equipment in a safe and effective manner
Establish appropriate procedures regarding handover of systems from construction to C&Q team as well as handover of systems from C&Q team to client
Establish appropriate metrics for measuring key project criteria
Ensure that project deliverables satisfy project requirements
Bachelor’s degree in Mechanical, Chemical or Electrical Engineering or equivalent
Six Sigma Certification preferred
15+ years of CQV experience in the life sciences industry
Strong working knowledge of commissioning, qualification and validation deliverables, team building and client relationship building
Experience with tracking progress according to schedules and cost estimates
Experience with training and mentoring junior staff members
Flexibility and willingness to travel and work at various clients’ locations.
Ability to negotiate/compromise with other project team members to achieve project goals
Proposal development experience
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industry guidance: ISPE Baseline Guide 5 Commissioning and Qualification, ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems - ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment , ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 - ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.