Senior Validation Engineer - GMP & Compliance Lead

PCI Pharma Services; Tennessee; On-site; USD 100,000 - 140,000; Full time

Job summary

PCI Pharma Services is seeking a Validation Engineer IV to lead and execute complex validation of GMP facilities and processes. You will develop master plans, protocols and reports, and coordinate cross-functional teams in a fast-paced contract manufacturing environment.

The role requires broad knowledge of validation practices, strong technical writing, and collaboration with quality, manufacturing and engineering groups to ensure regulatory compliance and successful project delivery.

Qualifications

• Bachelor’s degree in Engineering or related science with 8+ years in pharma/biopharma validation/quality/production/engineering.
• Experience in pharmaceutical/biopharma operations, engineering, manufacturing or quality environments.
• Experience developing strategies, master plans, protocols and reports for validation.
• Direct validation experience with processes including development of IQ/OQ/PQ protocols.
• Knowledge of regulatory inspections and current industry standards for validation of GMP facilities.

Responsibilities

• Author validation plans and develop specifications, trace matrices, and validation reports for equipment, utilities, and processes.
• Review commissioning, qualification and validation lifecycle documents.
• Provide direction on change controls and risk-based validation.
• Collaborate with Manufacturing, Engineering, QA and project management to deliver project milestones.
• Write validation SOPs and maintain validation status through periodic system reviews.
• Mentor colleagues on validation policies and procedures.

Skills

ISPE & PDA guidelines

Regulatory knowledge (FDA/ICH/ISO/EMA)

Technical writing

Biopharma unit operations

Team leadership

MS Office

Education

Bachelor’s degree in Engineering

Tools

MS Office Suite

Job description

PCI Pharma Services is seeking a Validation Engineer IV to lead and execute complex validation of GMP facilities and processes. You will develop master plans, protocols and reports, and coordinate cross-functional teams in a fast-paced contract manufacturing environment.

The role requires broad knowledge of validation practices, strong technical writing, and collaboration with quality, manufacturing and engineering groups to ensure regulatory compliance and successful project delivery.