Validation Engineer

Commissioning Partners LLC.; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Commissioning Partners LLC. is seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

The role involves developing and executing IQ/OQ/PQ protocols, reviewing design documents, performing field verification, and ensuring adherence to cGMP and FDA requirements while collaborating with Engineering, Manufacturing, Quality, and external vendors.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 3+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Hands-on experience with equipment qualification and validation.
• Experience with IQ/OQ/PQ, commissioning, FAT/SAT, and GMP documentation.
• Strong understanding of cGMP and FDA requirements.
• Excellent technical documentation and communication skills.
• Experience with manufacturing equipment, utilities, HVAC, automation, or process systems is a plus.

Responsibilities

• Develop and execute validation and qualification protocols, including IQ, OQ, and PQ.
• Support commissioning and qualification of manufacturing equipment, process systems, utilities, and facility systems.
• Review URS, functional specifications, design documents, P&IDs, and equipment documentation.
• Perform field verification, equipment walkdowns, functional testing, and qualification activities.
• Support FAT/SAT, startup, commissioning, and equipment turnover activities.
• Prepare and review validation protocols, test scripts, reports, traceability matrices, and validation documentation.
• Support deviations, change controls, CAPA, and validation-related investigations.
• Work closely with Engineering, Manufacturing, Quality, Maintenance, Automation, and external vendors.
• Ensure validation activities comply with cGMP, FDA, GAMP, and site procedures.
• Support inspection readiness and maintain accurate validation documentation.

Skills

Equipment qualification

Validation

IQ/OQ/PQ

GMP documentation

Technical communication

Education

Bachelor's degree in Engineering/Life Sciences

Tools

HVAC systems

Automation

Job description

We are seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

Responsibilities:

• Develop and execute validation and qualification protocols, including IQ, OQ, and PQ.
• Support commissioning and qualification of manufacturing equipment, process systems, utilities, and facility systems.
• Review URS, functional specifications, design documents, P&IDs, and equipment documentation.
• Perform field verification, equipment walkdowns, functional testing, and qualification activities.
• Support FAT/SAT, startup, commissioning, and equipment turnover activities.
• Prepare and review validation protocols, test scripts, reports, traceability matrices, and validation documentation.
• Support deviations, change controls, CAPA, and validation-related investigations.
• Work closely with Engineering, Manufacturing, Quality, Maintenance, Automation, and external vendors.
• Ensure validation activities comply with cGMP, FDA, GAMP, and site procedures.
• Support inspection readiness and maintain accurate validation documentation.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Hands-on experience with equipment qualification and validation.
• Experience with IQ/OQ/PQ, commissioning, FAT/SAT, and GMP documentation.
• Strong understanding of cGMP and FDA requirements.
• Excellent technical documentation and communication skills.
• Experience with manufacturing equipment, utilities, HVAC, automation, or process systems is a plus.