Validation Engineer

VALIDATION ENGINEER

Charles City, Iowa

$100,000 - $120,000 DOE

✈Relocation Assistance Available

Direct Hire

Kelly Engineering is partnering with a leading pharmaceutical manufacturing organization to hire a Validation Engineer for their growing operation in Charles City, Iowa.

This is an exciting opportunity to join a highly regulated GMP manufacturing environment supporting equipment and facility qualification activities for pharmaceutical production. The company is investing heavily in site growth and expansion, creating strong opportunities for long-term career development.

WHAT YOU'LL DO

• Develop and execute IQ, OQ, and PQ protocols and reports

• Support equipment and facility qualification activities throughout the manufacturing site

• Coordinate validation activities with Engineering, Maintenance, Quality, Operations, contractors, and vendors

• Maintain validated systems through change control processes

• Support revalidation efforts and continuous improvement initiatives

• Perform and oversee protocol execution, data collection, and final report generation

• Support FDA inspections and customer audits related to validation activities

• Ensure compliance with cGMP regulations and company procedures

WHAT WE'RE LOOKING FOR

• Bachelor's degree in Engineering or related technical discipline preferred

• 5+ years of validation experience

• Experience within a CDMO, pharmaceutical manufacturing, biotech manufacturing, API manufacturing, and/or pilot plant environment

• Experience authoring and executing IQ/OQ/PQ protocols and reports

• Strong understanding of cGMP regulations and validation requirements

• Experience supporting equipment qualification and facility validation activities

• Excellent communication and cross-functional collaboration skills

PREFERRED EXPERIENCE

• API manufacturing

• Pharmaceutical manufacturing

• Pilot plant operations

• Commissioning and qualification activities

• Distributed Control Systems (DCS)

WHY APPLY?

• Direct hire opportunity

• Relocation assistance available

• Growing pharmaceutical manufacturing site

• Exposure to large-scale validation and expansion projects

• Competitive salary and benefits package

If you're a Validation Engineer with pharmaceutical, biotech, CDMO, or API manufacturing experience, we'd love to speak with you.