Senior GMP Validation Lead

Precigen, Inc; Germantown (MD); On-site; USD 130,000 - 140,000; Full time

Job summary

Precigen, Inc. seeks a Lead Validation Engineer in Germantown, MD to drive site validation and qualification programs within GMP manufacturing, QC, and R&D operations.

You will develop strategies, oversee IQ/OQ/PQ activities, and provide technical guidance across cross-functional teams. The ideal candidate has 5+ years of GMP validation experience, strong project leadership, and familiarity with regulatory expectations (FDA/EU).

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related field.
• Minimum of five (5) years of GMP validation and qualification experience.
• Proven experience leading complex validation projects with cross-functional teams.
• Strong understanding of FDA/EU GMP requirements and data integrity principles.

Responsibilities

• Provide technical leadership for site validation and qualification activities across GMP facilities, utilities, and equipment.
• Lead complex qualification and validation projects from concept through implementation.
• Serve as Validation SME for GMP facilities, utilities, process equipment, and analytical instruments.
• Coordinate with Facilities, Manufacturing, QC, and R&D to maintain validated systems and ensure regulatory compliance.
• Develop validation strategies using risk-based methodologies (FDA/EU GAMP, ISPE).
• Author and review Validation Master Plans, Protocols, Reports, and SOPs.
• Lead IQ, OQ, and PQ activities for facilities, utilities, equipment, and systems.
• Support regulatory inspections, audits, and deviations as a Validation SME.

Skills

GMP Validation

Project Leadership

Technical Writing

Cross-functional Collaboration

Equipment Qualification

Environmental Monitoring

IQ/OQ/PQ

Education

Bachelor's degree in Engineering/ Life Sciences/ Biotechnology

Tools

CMMS

BMS/BAS

EMS

CAD

Quality Records Management

Validation Data Management Software

Job description

Precigen, Inc. seeks a Lead Validation Engineer in Germantown, MD to drive site validation and qualification programs within GMP manufacturing, QC, and R&D operations.

You will develop strategies, oversee IQ/OQ/PQ activities, and provide technical guidance across cross-functional teams. The ideal candidate has 5+ years of GMP validation experience, strong project leadership, and familiarity with regulatory expectations (FDA/EU).