Senior Lab CSV Engineer / Senior Validation Engineer

A leading organization in the life sciences sector is seeking a Senior Lab CSV / Validation Engineer to join their team in Muskegon, Michigan. This role is ideal for professionals with a strong background in laboratory equipment validation and computerized systems, particularly within regulated environments.

About the Role:

This position involves working independently to validate both simple and complex laboratory instruments. The successful candidate will collaborate with vendors to define testing requirements and ensure compliance with industry standards and internal procedures.

Key Responsibilities:

• Independently execute validation activities for lab instruments and computerized systems
• Draft and execute validation documentation, including Validation Plans, URS, IQ/OQ/PQ protocols, RTMs, VSRs, and more
• Conduct impact and risk assessments with a clear understanding of system operations
• Manage deviations and changes in accordance with project and quality standards
• Support system integration efforts, including data flow analysis and testing strategies
• Maintain accurate and compliant validation records
• Collaborate with cross-functional teams to ensure timely project delivery

Required Experience & Skills:

• Bachelor's degree or equivalent experience
• 4-6 years of relevant experience in validation or CSV roles
• Strong understanding of 21 CFR Part 11 and cGxP requirements
• Experience with complex lab systems and integration design
• Proficiency in Microsoft Office and general PC tools
• Excellent communication, problem-solving, and organizational skills
• Ability to work both independently and as part of a team
• Demonstrated ability to manage multiple priorities in a fast-paced environment

Additional Information:

• This is a full-time, on-site position based in Muskegon, MI
• Applicants must be authorized to work in the U.S. without current or future sponsorship