Sr. GMP Technician

Sr. GMP Technician

General Requirements:

• Following local procedures
• Completing required training
• Adhering to GMP requirements for documentation of activities
• Cleaning, sanitizing, and breaking down equipment
• Operating GMP manufacturing/cleaning equipment
• Pharmaceutical manufacturing within oral solid dosage or with dry powder inhalers- the equipment
• OEB classifications

Education:

• High School Diploma
• Certifications: Not required, but a certification in pharm processing would be beneficial

Experience:

• 2-4 years’ experience in a GMP facility

Responsibilities:

• Prepare the appropriate disinfectants as per SOP.
• Understand the dwell time for all cleaning agents/chemicals.
• Cleaning of the processing rooms following manufacturing processes and as required per procedure. Remove all trash/biohazard waste bags from the MFG area.
• Stocks all gowning materials in all air locks and locker rooms.
• Execute cleaning of major and minor pieces of equipment and ancillary equipment
• Disassembly and reassembly of equipment per procedure (as required)
• Perform cleaning activities on the isolators and filling line
• Perform cleaning verification activities to support cleaning validation
• Accurately documenting activities in the appropriate logbooks.
• Able to work with a respirator during special assignments, if required.
• Maintain materials inventory.
• Report any unexpected observations to area management.
• Perform tasks under minimal supervision, and within tight timelines to meet production schedule.
• Coordinate with engineers & maintenance personnel in facility upkeep
• Author and revise SOPs and logbooks.
• Reviews logbooks at the end of the shift to ensure proper GDP.

Requirements:

• Good interpersonal skills and attention to detail.
• Previous experience in cleaning the GMP area is required.
• Must be able to follow GMP regulations during operations, including adherence to written procedure and contemporaneous documentation.
• Must be able to record data accurately and legibly.
• Ability to perform in a team setting in a controlled environment for long periods of time.

Physical Requirements:

• Physically capable of donning and wearing cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees
• Perform operations within ISO Class clean rooms
• Employees must be able to lift and/or move up to 40 pounds
• Must be able to squat, bend, kneel, and or reach for 40% of a shift
• Must be able to stand, walk, and/or move about for 40% of a shift