Validation Program Lead, GMP & Gene Therapy

Precigen; Germantown (MD); On-site; USD 115,000 - 170,000; Full time

Job summary

Precigen in Germantown, MD seeks a Lead Validation Engineer to guide site validation activities across GMP manufacturing, QC, facilities, and R&D. You will lead IQ/OQ/PQ programs for equipment and utilities, develop risk-based strategies, and ensure compliance with FDA/EU GMP standards.

The role demands senior technical leadership, strong problem-solving, and the ability to manage multiple high-priority initiatives while driving continuous improvement across the site validation program.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related field.
• 5+ years of GMP validation/qualification experience in pharma/biotech.
• Experience leading complex validation projects with cross-functional teams.
• Extensive qualification programs for equipment, utilities, facilities, and processes.
• Experience authoring Validation Master Plans, Protocols, Reports, and SOPs.
• Strong FDA/EU GMP knowledge and data integrity understanding.

Responsibilities

• Provide technical leadership for site validation and qualification activities across GMP systems.
• Lead complex IQ/OQ/PQ projects for equipment, facilities, and utilities.
• Serve as Validation SME for facilities, utilities, equipment, and instruments.
• Coordinate with Facilities, Manufacturing, Quality, and R&D to maintain validated state.
• Develop risk-based validation strategies in line with GMP standards.
• Support regulatory inspections and audits as the Validation SME.

Skills

GMP Validation

Cross-functional leadership

Regulatory compliance

Project management

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

Tools

CMMS

BMS/BAS

EMS

CAD

Job description

Precigen in Germantown, MD seeks a Lead Validation Engineer to guide site validation activities across GMP manufacturing, QC, facilities, and R&D. You will lead IQ/OQ/PQ programs for equipment and utilities, develop risk-based strategies, and ensure compliance with FDA/EU GMP standards.

The role demands senior technical leadership, strong problem-solving, and the ability to manage multiple high-priority initiatives while driving continuous improvement across the site validation program.