Senior Validation Engineer – GMP & Process Excellence

Precigen; Germantown, Northern (MD, KY); Hybrid; USD 130,000 - 140,000; Full time

Job summary

Precigen in Germantown, MD seeks a Lead Validation Engineer to lead site validation and qualification activities for GMP manufacturing, QC, facilities, and R&D. The role requires technical leadership on IQ/OQ/PQ across equipment, utilities, and facilities, with cross-functional collaboration and risk-based validation strategies.

The ideal candidate will have a strong GMP background, experience with regulatory expectations, and the ability to manage multiple high-priority initiatives while

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum of five years' GMP validation experience in pharma/biotech/medical device.
• Proven ability to lead complex validation projects and coordinate cross-functional teams.
• Experience with equipment, utility, facility, and process qualification in GMP environments.
• Experience authoring Validation Master Plans, Protocols, Reports, and related docs.

Responsibilities

• Provide technical leadership for site validation and qualification activities (GMP制造、实验室、公用设施、设施系统).
• Lead complex qualification projects from concept through implementation (new equipment, facility expansion, process improvements).
• Serve as Validation SME for GMP facilities, utilities, equipment, and analytical instruments.
• Coordinate with Facilities, Manufacturing, Quality, R&D, and vendors to maintain validated systems and ensure compliance.
• Oversee qualification activities for HVAC, backup power, water systems, clean utilities, autoclaves, and related equipment.
• Develop validation strategies using risk-based methods aligned with FDA/EU GMP/ISPE/GAMP.

Skills

GMP validation

Qualification programs

IQ/OQ/PQ

Environmental Monitoring

FDA regulations

Project management

Technical writing

Cross-functional teamwork

BMS/BAS

Education

Bachelor's degree in Engineering

5+ years GMP validation experience

Tools

CMMS

CAD

EMS

QMS

Job description

Precigen in Germantown, MD seeks a Lead Validation Engineer to lead site validation and qualification activities for GMP manufacturing, QC, facilities, and R&D. The role requires technical leadership on IQ/OQ/PQ across equipment, utilities, and facilities, with cross-functional collaboration and risk-based validation strategies.

The ideal candidate will have a strong GMP background, experience with regulatory expectations, and the ability to manage multiple high-priority initiatives while