Validation Engineer – Equipment & Utilities

Title: Equipment & Utility Validation Engineer / Specialist

Location: Frederick, Maryland (Onsite) – Need Local or Nearby non-local accepted who can relocate at their own cost.

Duration: 6+ months

 

Job Overview:
We are seeking highly experienced Equipment & Utility Validation Engineers/Specialists to support pharmaceutical and biotech manufacturing operations in a GMP-regulated environment. The ideal candidate will have strong expertise in commissioning, qualification, validation (CQV), and utility systems validation with hands-on experience in FDA-regulated facilities.

 

Key Responsibilities:

• Execute equipment and utility qualification activities including IQ, OQ, and PQ
• Develop, review, and execute validation protocols and reports
• Perform commissioning and qualification (CQV) activities for manufacturing and utility systems
• Validate clean utilities including WFI, RO, Clean Steam, HVAC, and compressed gases
• Support deviation investigations, CAPA, change controls, and risk assessments
• Ensure compliance with GMP, FDA, ISPE, and regulatory standards
• Collaborate with Engineering, QA, Manufacturing, and Validation teams
• Maintain accurate validation and compliance documentation

 

Required Skills:

• Strong experience with Equipment & Utility Validation in Pharma/Biotech environments
• Hands-on expertise with IQ/OQ/PQ and CQV processes
• Knowledge of GMP/GxP compliance requirements
• Experience with utility systems validation and process equipment qualification
• Excellent documentation and communication skills
• Ability to work independently in fast-paced regulated environments

 

Preferred:

• Experience supporting FDA audits and inspections
• Familiarity with Kneat, ValGenesis, or other validation management tools
• Strong troubleshooting and analytical skills