Enviromental Support Tech
What this job involves: The Environmental Support Tech position within this biotech company entails a strong focus on adhering to current Good Manufacturing Practices (cGMPs), following established cleaning practices and procedures, and ensuring compliance with quality standards and regulations. The primary goal of the cleaning and sanitization program is to effectively manage microbial contamination and serve as a corrective measure when viable excursion contamination occurs. Strict adherence to Standard Operating Procedures (SOPs) is necessary to maintain acceptable environmental monitoring results within the cleaned GMP environment.
What your day-to-day will look like:
- Perform sanitization and cleaning per governing SOPs in GMP spaces.
- 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 disposal of waste from GMP manufacturing process area waste receptacles daily.
- 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.
- 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.
- Must pass a gowning qualification test in order to enter the controlled environment.
- Control what enters the GMP process areas.
- 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.
Work Schedule:
1 PM - 9:30 PM; Weekends and Holidays Availability Required; 24/7 Operation
Desired or preferred experience and technical skills:
- Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus.
- Knowledge of Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred.
- Prior experience in janitorial, custodial or Environmental Support Tech role, preferably in a regulated industry such as biotech or pharmaceuticals is a plus.
Required Skills and Experience:
- High School Diploma or equivalent.
- English usage, spelling, grammar and punctuation.
- Attention to detail is required.
- Excellent attendance record.
- Must follow work instructions.
- 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 ISO9, ISO 8 or ISO 7 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.
- 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.
- Company policies and practices, including safety rules and regulations.
