GMP Technician

Work Location: Middlesex County, Massachusetts

Summary:

The GMP Technician is responsible for ensuring compliance with Standard Operating Procedures (SOPs), maintaining clean and controlled environments, and adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). This role requires ongoing training, attention to detail, and the ability to perform physical tasks as needed.

Responsibilities:

• Execute cleaning and disinfecting operations in controlled environments, following strict guidelines and SOPs.
• Maintain accurate and detailed documentation in compliance with GMP and GDP standards.
• Participate in continuous training, including cGMP, technical skills, safety, and performance improvement programs.
• Perform micro-cleaning of all surfaces, including ceilings, walls, equipment, and floors, ensuring all procedures are followed precisely.
• Identify and report deviations in cleaning processes, and assist in implementing corrective and preventative actions.
• Assist in reviewing changes to cGMP documentation and participate in cross-training of team members.
• Report any damage, suspicious activities, or unsafe conditions within the work area to the supervisor.
• Work flexible hours, including holidays, weekends, overtime, and special assignments as required.

Qualifications:

• Ability to work flexible hours, including holidays, weekends, overtime, and special assignments.
• Ability to lift up to 40 lbs, work overhead, and stand for extended periods.
• Proficient in English with good handwriting and minimal errors; bi-lingual skills are a plus.
• Previous aseptic cleaning experience preferred.
• Familiarity with pharmaceuticals, bio-research, semiconductor, or medical device manufacturing cleanroom facilities preferred.
• College education preferred.
• Strong attention to detail and ability to follow SOPs and documentation requirements precisely.
• Commitment to ongoing training and adherence to safety and performance standards.

Published Category: Manufacturing & Technical Operations