Sr. GMP Technician

This position is onsite in Rahway, NJ with one of our Global Pharmaceutical clients through Kelly FSP (Functional Service Provider), a managed solution provider and business unit of Kelly Services, Inc. This is a full-time role offering full benefit options, including Medical, Dental, Vision, 401K, and paid time off (holiday, vacation, sick/personal time).

About the Role

As a Senior GMP Technician, you will support GMP manufacturing operations by adhering to procedures, maintaining equipment, and ensuring compliance with documentation and cleaning standards.

Responsibilities

• Prepare disinfectants as per SOP and understand dwell times for cleaning agents/chemicals.
• Clean processing rooms following manufacturing processes and as required per procedure.
• Remove trash and biohazard waste bags from the manufacturing area.
• Stock gowning materials in air locks and locker rooms.
• Execute cleaning of major and minor equipment, including disassembly and reassembly per procedure.
• Perform cleaning activities on isolators and filling lines, including cleaning verification for validation support.
• Accurately document activities in logbooks and review logbooks at the end of shifts to ensure proper Good Documentation Practices (GDP).
• Work with a respirator during special assignments, if required.
• Maintain materials inventory and report unexpected observations to area management.
• Perform tasks under minimal supervision within tight timelines to meet production schedules.
• Coordinate with engineers and maintenance personnel for facility upkeep.
• Author and revise SOPs and logbooks.

Requirements

• 2–4 years of experience in a GMP facility.
• Previous experience cleaning GMP areas.
• High School Diploma (certification in pharmaceutical processing is beneficial).
• Ability to follow GMP regulations, including adherence to written procedures and contemporaneous documentation.
• Strong interpersonal skills, attention to detail, and ability to record data accurately and legibly.
• Ability to work in a team setting within a controlled environment for long periods.

Physical Requirements

• Capable of donning and wearing cleanroom/protective gowning and equipment (e.g., gowns, goggles, face shields, gloves).
• Must be able to lift and/or move up to 40 pounds.
• Able to squat, bend, kneel, and/or reach for 40% of a shift.
• Able to stand, walk, and/or move about for 40% of a shift.
• Perform operations within ISO Class clean rooms.

Benefits

• Medical, Dental, and Vision coverage.
• 401K retirement savings plan.
• Paid time off, including holiday, vacation, and sick/personal time.