Posted in Other 3 days ago.
Type: Full Time
Environmental Support Technician
Lead skilled Environmental Support Techs. Responsibilities include: Floor direction, Training, documentation.
The GMP Environmental Support Technician works in activities associated with the sanitization of controlled areas in accordance with internal procedures, protocols, and cGMP's. The incumbent will follow all applicable standard operation procedures (SOP), guidelines and policies to ensure sanitary conditions are maintained, that appropriate room and equipment sanitization records are neat and accurate, and that professional behavior is displayed within the controlled areas. The incumbent will receive daily production schedule direction from the Lead and/or area management. The incumbent plays a critical role in assuring sanitary conditions of the controlled areas is maintained to manufacture biopharmaceuticals.
This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the cleaning and sanitization program is to control microbial contamination and to serve as a corrective action for the loss of control for viable excursion contamination. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment.
This is a full time, non-exempt position.
The incumbent may be required to work weekends, holidays, and overtime if required.
Responsible for routine daily, weekly, monthly, quarterly, and additional frequency room sanitization in GMP manufacturing process areas
Responsible for non-routine sanitization in the GMP manufacturing process areas due to environmental excursion, process requirements, or facility maintenance and/or construction
Responsible for verifying that the proper sanitization disinfectant rotation is followed and that the proper sanitization disinfectant is used for each cleaning assignment
Responsible for completing required GMP documentation to ensure records are properly and accurately maintained
Responsible for mixing and disposal of sanitization solutions on a daily basis
Responsible for disposal of waste from GMP manufacturing process area waste receptacles on a daily basis
Responsible for ordering general sanitization supplies
Responsible for organization and upkeep of sanitization supply areas
Responsible to participate in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering
Other Responsibilities Include:
Collaborate with Manufacturing, GMP Operations Manager, and Quality teams to manage schedules necessary to clean the GMP controlled environment and support areas to comply with GMP requirements
Participate in required training on the use of sanitization disinfectants and equipment
Strictly follow Standard Operating Procedures
Follow cGMPs as outlined in 21 CFR Part 211
Must pass a sterile gowning qualification test in order to enter and sanitize the GMP process rooms
Control what enters the GMP process areas
Adhere to procedures while performing cleaning and sanitization activities
Sanitization activities will be performed with ceiling mops, wall mops, floor mops, and wipers
Understands and follows proper solvent handling procedures (EHS) and personal protective equipment (PPE)
Performs related duties as assigned
Accurate GMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)
Communicating clearly and concisely, both orally and in writing
Ability to read, write and understand documentation in English
Ability to work in a team environment and independently
Establish and maintaining collaborative working relationships with internal and external customers
Providing excellent customer service with both internal and external customers
Current Good Manufacturing Practices (cGMP) is a plus but not required
Good Documentation Practices (GDP) is a plus but not required
Company policies and practices, including safety rules and regulations
Education and/or Experience:
High School Diploma or equivalent
Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus but not required
English usage, spelling, grammar and punctuation
Business computer hardware and software applications
Attention to detail is required
Excellent attendance record
Must follow work instructions
Physical Requirements and Working Environment:
No make-up, nail polish, and/or jewelry may be worn in the GMP process areas
Incumbent is subject to extended periods of standing, walking, pushing and pulling, bending and crouching, climbing, and lifting of equipment and/or materials weighing up to 50 pounds
Continuous mental and visual attention to manufacturing functions
Continuous standing and walking throughout work day
Majority of time spent in ISO 8 (Class 100K) or ISO 7 (Class 10K) cleanroom, fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles and/or face shield
Working in the ancillary support space adjacent to the ISO areas described above to ensure cleanliness
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