Lead CQV Engineer
Lead CQV Engineer
Posted on :
13-05-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2832976
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
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
Benefits
High growth potential and fastpaced organization with a peoplefocused culture
Competitive pay plus performancebased incentive programs
Companypaid Life ShortTerm and LongTerm 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
Competitive pay plus performancebased incentive programs
Companypaid Life ShortTerm and LongTerm 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
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
Employment Type
Full Time
Key Skills
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