Lead CQV Engineer
3 weeks ago
This role is 100% onsite at the Easton, OH location. The role requires strong validation skills and experience as well as strong people and communication skills. The position will support multiple projects across all of the Pharma Client facilities and ensure validation deliverables are met. This will require understanding project schedules, validation deliverables, and knowledge of current validation standards. Resource must be independent and willing to work with multiple SMEs.
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes
- 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
- 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
- Receipt Verification (RV)
- Experience in GMP regulated Environment
· 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
Requirements
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
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