CQV Lead / CQV Project Manager (Pharmaceutical Industry) - Easton OH at Confidential company
About the Job
Location: Onsite Easton OH
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
- Running test scripts and documenting results
- Adherence with project schedule for all assigned activities
- Maintaining clear, detailed records qualification and validation
- Documenting impact and risk assessments as part of a team
- Completing user interface testing, software verification, and complete alarm testing on automated systems
- Developing, reviewing, and executing testing documentation
- Making recommendations for design or process modification based on test results when executing test scripts
- General understanding of capital equipment implementation and process knowledge
- Understanding validation documents, URS, IQ, OQ, PQ
Candidate Requirements
- Minimum 12+ years of Work Experience
- Expertise in Production Equipment, Facilities (Clean Room Qualification with EMPQ), and Utilities (WFI, HVAC, Compressed Gases) for the following deliverables:
- Reviewing Factory Acceptance Testing (FAT) documentation.
- Reviewing and updating URS, System Level Impact Assessments (SLIA), and System Classification Assessments (SCA).
- Authoring Validation Project Plans.
- Authoring Requirements Traceability Matrix (RTM)
- Execution support of the following documents:
- Receipt Verification (RV)
- Site Acceptance Testing (SAT) protocols.
- Commissioning Protocols (IV, OV)
- Drafting and Executing Data Integrity (DI) Assessment
- Experience in GMP regulated Environment
- Should have handled Multiple validation projects
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Immediate interviews!