Validation Engineer II - Sterile GMP Manufacturing

Tolmar; Windsor (CO); On-site; USD 90,000 - 100,000; Full time

Job summary

Tolmar is seeking a Validation Engineer II in Windsor, CO to independently plan, execute, and document validation activities in a sterile injectable manufacturing environment.

You will coordinate cross‑functional validation plans, protocols, and reports, and lead IQ/OQ/PQ validation for equipment, facilities, utilities, and processes while supporting continuous improvement and regulatory readiness.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Minimum of 2 years’ validation experience, preferably in sterile pharma/biotech.
• Strong understanding of cGMP, FDA and EU regulatory requirements.
• Familiarity with aseptic processing, cleanrooms and environmental monitoring preferred.
• Experience with validation software or electronic document management systems preferred.

Responsibilities

• Plan and coordinate validation activities for cross‑functional projects (plans, protocols, reports).
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
• Lead cleaning and sterilization validation activities (autoclaves, SIP).
• Conduct risk assessments (FMEA) and support change control evaluations.
• Analyze validation data, prepare reports, ensure audit readiness.
• Collaborate with QA, Manufacturing, Engineering, and QC.
• Maintain validation lifecycle documentation per internal procedures.

Skills

GMP knowledge

Technical writing

Project management

Communication

Problem solving

Education

Bachelor’s degree in Engineering or Life Sciences

2+ years validation experience

Sterile pharma/biotech exposure preferred

Regulatory knowledge (FDA/EU)

Tools

Validation software

Electronic Document Management Systems

Microsoft Office

Job description

Tolmar is seeking a Validation Engineer II in Windsor, CO to independently plan, execute, and document validation activities in a sterile injectable manufacturing environment.

You will coordinate cross‑functional validation plans, protocols, and reports, and lead IQ/OQ/PQ validation for equipment, facilities, utilities, and processes while supporting continuous improvement and regulatory readiness.