Lead CQV Engineer

Pharmatek Consulting•Easton, OH

1d•Onsite

About The Position

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

Responsibilities

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

Benefits

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