Senior Validation Engineer
$110,000–$130,000 year
On-siteRamsey, Minnesota, United States
Job Summary
Lead validation strategy, execution, and continuous improvement for custom automated converting, packaging, and coating equipment while ensuring compliance with industry standards. Serve as the technical expert for equipment, systems, and process validation by overseeing monitoring, sampling, and testing to confirm protocol adherence. Author, review, and approve critical documentation including FMEA, FDS, SDS, IQ, OQ, and PQ. Conduct risk assessments, evaluate impact assessments for system changes, and lead revalidation activities. Mentor Validation Engineers and coordinate cross-functional efforts across engineering, manufacturing, and quality teams to meet project timelines. Support customer interactions through technical discussions and audits. Full-time, on-site role with core hours Monday through Friday, 9:00 a.m. to 3:30 p.m., requiring occasional travel and time in machine assembly environments.
Required Qualifications
- Bachelor's degree in engineering or other relevant technical discipline
- 7+ years of experience in validation of manufacturing equipment and/or software validation
- Demonstrated experience leading validation efforts and influencing cross-functional teams
- Strong leadership and mentoring capability
- Advanced technical expertise in validation methodologies and regulatory requirements
- Customer/Client Focus with ability to lead technical discussions
- Strong analytical and problem-solving skills with a risk-based mindset
- Ability to manage multiple complex projects simultaneously
- Excellent verbal and written communication skills
- Working knowledge of mechanical and electrical systems, pneumatics, and hydraulics
- Advanced blueprint/schematic interpretation skills
- High attention to detail with a focus on quality and compliance
- Must be able to lift or move objects up to 25 pounds
- Must be available for travel based on project or customer needs
Desired Qualifications
- Experience working in regulated environments (medical device, pharmaceutical, or similar) preferred
- Proficiency with Microsoft Office products; experience with Adobe Creative Suite and FrameMaker preferred
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