What are the responsibilities and job description for the Validation Engineer - Medical Device position at IntePros?
Validation Engineer – Medical Device Industry
Location: Lafayette, CO
Industry: Medical Device / Regulated Manufacturing
No C2C or 3rd party will be considered.
Must have prior Medical Device experience to be considered.
IntePros is partnering with a global medical device leader to hire a Validation Engineer. This role offers the opportunity to contribute directly to the validation of critical manufacturing equipment and processes in a highly regulated, fast-paced environment.
Overview:
As a Validation Engineer, you will be responsible for authoring, executing, and reviewing validation protocols (IQ/OQ/PQ) related to new and existing manufacturing processes, test systems, and equipment. You will work cross-functionally with engineering, quality, and production teams to ensure compliance with internal procedures, FDA regulations, and ISO standards.
Key Responsibilities:
- Develop and execute equipment, process, and test method validation protocols (IQ/OQ/PQ)
- Ensure validation activities meet FDA, ISO 13485, and internal quality system standards
- Support new equipment integration, process changes, and ongoing improvement initiatives
- Collaborate with Quality, Manufacturing, and R&D teams to define validation requirements
- Perform risk assessments (FMEA), participate in root cause analysis, and support CAPA activities
- Prepare and maintain detailed validation documentation, including traceability and change control
- Participate in audits and regulatory inspections as a subject matter expert for validation processes
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
- Minimum 3 years of hands-on experience in validation within a regulated environment (medical device preferred)
- Proficient in drafting and executing IQ/OQ/PQ protocols and reports
- Strong understanding of GMP, QSR, ISO 13485, and related regulatory standards
- Experience with validation tools and systems (TrackWise, Minitab, etc.) is a plus
- Excellent technical writing and communication skills
