Validation Maintenance Technician - Lab Instrument - Life Sciences Client Site

The Validation Maintenance Technician will support thermal mapping and validation activities for autoclaves and temperature-controlled environments within a regulated pharmaceutical manufacturing environment. This role requires hands-on technical expertise, strong documentation skills, and the ability to work independently while collaborating with cross-functional teams. The technician will be responsible for executing validation protocols, calibrating equipment, and ensuring compliance with regulatory standards.

• Participate in weekly planning meetings to review upcoming assignments.
• Evaluate autoclave systems to understand operational criteria, utilities, and sanitary connections.
• Generate and modify validation protocols specific to autoclave and cycle parameters.
• Set up and execute validation tasks using appropriate instrumentation and software.
• Calibrate sensors and verify performance using built-in software and reference tools.
• Collaborate with Process Engineers and Production personnel to design validation load patterns.
• Install thermocouple wires and biological indicators (Spore Strips/Ampoules) in load configurations.
• Execute thermal mapping studies and retrieve biological samples for testing.
• Document all validation activities and findings in real-time during protocol execution.
• Analyze thermal mapping data and generate qualification and summary reports.
• Investigate deviations, perform root cause analysis, and implement corrective actions.
• Repeat validation cycles as required based on load pattern frequency and protocol scope.

• Working knowledge of validation principles and practices in a regulated manufacturing environment.
• Familiarity with autoclave operation, utilities, automation, and cycle load handling.
• Understanding of USDA and 9CFR regulatory requirements.
• Strong analytical and troubleshooting skills.
• Experience implementing corrective and preventive actions (CAPA).
• High attention to detail in documentation and execution of validation activities.
• Excellent verbal and written communication skills.
• Ability to work collaboratively across departments.
• Commitment to safety protocols and awareness of hazards (e.g., high-pressure steam, enclosed spaces).

• Flexibility to work irregular hours, including evenings, weekends, and holidays.
• Availability for frequent travel, sometimes on short notice.
• Adaptability to changing scopes of work and fluctuating activity volumes.

• Completion of Health, Safety, and Environmental (HSE) training.
• Basic gowning training for access to controlled production areas.
• Ability to work independently after initial onboarding and training.