Senior Validation Engineer IV - GMP Compliance & Leadership

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 110,000 - 150,000; Full time

Job summary

PCI Pharma Services in New Hampshire is seeking a senior Validation Engineer IV to lead complex validation activities within a cGMP contract manufacturing setting. You will author plans, develop specifications, and guide IQ/OQ/PQ protocols across multiple facilities.

Collaborate with Manufacturing, Engineering, Quality Assurance and project management to hit schedules, mentor teammates, and drive continuous improvement while ensuring FDA/ICH/ISO/EMA regulatory compliance.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline; 8+ years of pharmaceutical/biopharmaceutical industry experience.
• Experience in pharmaceutical/biopharmaceutical operations, engineering, quality environments.
• Experience with validation: equipment qualification, process validation, or cleaning validation.
• Direct validation experience with development of strategies, master plans, protocols and reports.
• Knowledge of ISPE, PDA guidelines; FDA, ICH, ISO, EMA regulations.

Responsibilities

• Author validation plans and oversee development of specifications, IQ/OQ/PQ protocols.
• Review and approve validation lifecycle documentation.
• Provide direction on change control for equipment, utilities, facilities, and processes.
• Collaborate with Manufacturing, Engineering, QA, and project management to meet deliverables.
• Develop validation SOPs and monitor validation status.
• Mentor colleagues on validation policies.

Skills

Validation expertise

Regulatory knowledge

Technical writing

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or related scientific discipline

Tools

Microsoft Office Suite

Job description

PCI Pharma Services in New Hampshire is seeking a senior Validation Engineer IV to lead complex validation activities within a cGMP contract manufacturing setting. You will author plans, develop specifications, and guide IQ/OQ/PQ protocols across multiple facilities.

Collaborate with Manufacturing, Engineering, Quality Assurance and project management to hit schedules, mentor teammates, and drive continuous improvement while ensuring FDA/ICH/ISO/EMA regulatory compliance.