Senior Validation Engineer
EyePoint
5 hours ago
Remote friendly (Northbridge, MA)
United States
Operations
Responsibilities
- Lead development, execution, and approval of Process Validation (PV) and Process Performance Qualification (PPQ) protocols/reports aligned with FDA, EMA, and ICH guidelines.
- Support process control strategy and Continued Process Verification (CPV) planning.
- Plan, execute, and document facility, equipment, and utilities qualification activities (IQ/OQ/PQ).
- Lead/support Computer System Validation (CSV) per GAMP 5 and 21 CFR Part 11, including automation/control validation.
- Maintain validation documentation in inspection-ready state for internal audits, regulatory inspections, and pre-approval inspection (PAI) preparation.
- Perform validation lifecycle gap assessments, develop remediation plans, and drive gap closure.
- Contribute to Validation Master Plans (VMPs), validation SOPs, risk assessments, and quality system documentation.
- Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory Affairs.
- Serve as SME during audits/inspections; mentor junior staff and support validation/compliance training.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
- 8–12+ years validation experience in pharma/biotech/regulated industry.
- Demonstrated leadership of process validation and PPQ for NDA/BLA submissions or commercial launches.
- Strong facility/equipment/utilities qualification experience (incl. cleanrooms; critical utilities).
- Hands-on CSV/automation validation (PLC, SCADA, HMI; data integrity).
- Regulatory inspection support experience (incl. PAI).
- Knowledge of FDA/EMA/ICH (Q7/Q8/Q9/Q10/Q12) and EU Annex 15; data integrity principles.
Skills/Abilities
- Risk-based validation lifecycle management; strong technical writing and documentation review.
- Ability to interpret/apply regulatory requirements; analytical/problem-solving skills; excellent communication and leadership.
Working Conditions
- Office and GMP manufacturing/cleanroom environments; some travel for vendor visits/FAT/SAT.
Salary Range
- $128,750–$163,083 USD.
- Lead development, execution, and approval of Process Validation (PV) and Process Performance Qualification (PPQ) protocols/reports aligned with FDA, EMA, and ICH guidelines.
- Support process control strategy and Continued Process Verification (CPV) planning.
- Plan, execute, and document facility, equipment, and utilities qualification activities (IQ/OQ/PQ).
- Lead/support Computer System Validation (CSV) per GAMP 5 and 21 CFR Part 11, including automation/control validation.
- Maintain validation documentation in inspection-ready state for internal audits, regulatory inspections, and pre-approval inspection (PAI) preparation.
- Perform validation lifecycle gap assessments, develop remediation plans, and drive gap closure.
- Contribute to Validation Master Plans (VMPs), validation SOPs, risk assessments, and quality system documentation.
- Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory Affairs.
- Serve as SME during audits/inspections; mentor junior staff and support validation/compliance training.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
- 8–12+ years validation experience in pharma/biotech/regulated industry.
- Demonstrated leadership of process validation and PPQ for NDA/BLA submissions or commercial launches.
- Strong facility/equipment/utilities qualification experience (incl. cleanrooms; critical utilities).
- Hands-on CSV/automation validation (PLC, SCADA, HMI; data integrity).
- Regulatory inspection support experience (incl. PAI).
- Knowledge of FDA/EMA/ICH (Q7/Q8/Q9/Q10/Q12) and EU Annex 15; data integrity principles.
Skills/Abilities
- Risk-based validation lifecycle management; strong technical writing and documentation review.
- Ability to interpret/apply regulatory requirements; analytical/problem-solving skills; excellent communication and leadership.
Working Conditions
- Office and GMP manufacturing/cleanroom environments; some travel for vendor visits/FAT/SAT.
Salary Range
- $128,750–$163,083 USD.