Senior Validation Project Lead/Manager
On-site · North Carolina, United States or Virginia, United States
Job Summary
Senior Validation Project Lead/Manager to lead compliance, commissioning and validation (CQV) activities for life sciences facilities. Responsible for supporting client commissioning/validation for facility, utility, equipment, cleaning and process validation projects; preparing and executing lifecycle documents; participating in various stages of clinical or commercial production; writing summary reports for validation/qualification protocols; developing validation plans and strategies; coordinating protocol execution with manufacturing, facilities and project management; managing multiple projects to meet client priorities; and delivering practical problem-solving while representing Compli at client sites and interacting with clients, contractors, management and peers. Requires minimum 7 years CQV experience in aseptic/liquid fill facilities, utilities and systems, a bachelor’s degree in a related life sciences field, strong understanding of validation principles and GMP/ISPE practices, SME capability in a validation area, and strong technical writing and communication skills. Travel locally to VA/MD/NC; travel to East Coast or Midwest for extended on-site services.
Required Qualifications
- Minimum 7 years CQV experience with aseptic liquid fill facilities, utilities, equipment and systems
- Bachelor’s degree in a related life sciences or requisite industry training and experience
- Ability to converse about scientific matters
- Ability to work independently or in collaboration with others
- In-depth understanding and application of validation principles, concepts, practices and standards
- Considered a Subject Matter Expert (SME) in one area of validation
- Proficient in current Good Manufacturing Practices and other applicable regulations
- Experience with ISPE and development/execution of system life cycle deliverables (URS, SRS, FRS, DDS, RTM, Unit, Integration, UAT, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR)
- Excellent written communication skills with emphasis in technical writing
- Proficient in Microsoft Word, Excel, Power Point and Project
- Travel: Local to Virginia or Maryland or North Carolina areas; East Coast/Midwest on-site services
Additional Requirements
- This role is not open to C2C staffing.
This role has closed. Sorce can match you with similar open roles and apply on your behalf.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.