Senior QC Lab Equipment Validation Engineer
HKA Enterprises Industrial Solutions•Kalamazoo, MI
About The Position
We are seeking a Senior QC Lab Equipment Validation Engineer to support validation and lifecycle management of laboratory instruments and systems within a regulated environment. This role is critical to ensuring compliance with quality standards and regulatory requirements through validation activities, documentation, and continuous improvement initiatives. The ideal candidate brings strong experience in validation, quality systems, and laboratory environments, along with the ability to manage multiple priorities and work cross-functionally.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5–7 years of experience in validation, quality assurance, or process engineering
- Hands-on experience with IQ/OQ/PQ validation protocols
- Strong knowledge of regulatory requirements (FDA, ISO, cGMP)
- Experience with change control, deviations, and CAPA processes
- Ability to manage multiple projects and work independently
Nice To Haves
- Experience in QC laboratory environments (pharma, biotech, or related industry)
- Familiarity with laboratory instrumentation and controlled temperature units (CTUs)
- Experience reviewing vendor validation documentation
- Strong technical writing and documentation skills
- Experience supporting audits and regulatory inspections
Responsibilities
- Manage lifecycle activities for Quality Control (QC) laboratory instruments and associated software systems
- Develop, execute, and review validation protocols (IQ/OQ/PQ) for analytical instruments and controlled temperature units (CTUs)
- Author, revise, and retire validation documentation and Standard Operating Procedures (SOPs)
- Review and approve vendor-supplied validation documentation to ensure compliance with site and regulatory requirements
- Lead change control activities, including authoring, implementation, and tracking of changes
- Investigate deviations and lead CAPA (Corrective and Preventive Action) activities
- Perform periodic reviews of laboratory instruments and systems
- Support audits and inspections by providing validation documentation and responses
- Escort and coordinate with onsite vendors performing maintenance and calibration activities
- Collaborate with cross-functional teams to support compliance, process improvements, and operational efficiency
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
101-250 employees
