The Cleaning Technician position is responsible for the disassembly inspecting parts/assembly and cleaning of critical equipment associated with manufacturing equipment in the production of BacT/Alert bottles in a cGMP compliant manner. The position will require periodic infrastructure cleaning (maintain clean work environment). The position requires utilizing tools, cleaning chemicals, documentation, inspection, preventive maintenance, and disassembly of processing equipment cleaning of manufacturing equipment parts and assembly of processing equipment, preparing bulk tubing kits and maintaining daily use inventory. Additionally this individual will complete all applicable paperwork associated with cleaning records and equipment cleaning logs. This requires strong communication and team work with team members on different shifts. Access and understand use of Blue Mountain CMMS program to complete periodic scheduled PM’s.
- Executes production activities per Manufacturing Directions, comply with all job related SOP instructions in a safe manner.
- Assist with executing validation protocols associated with manufacturing equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state to include working with other department.
- As necessary, provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture of product.
- Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns.
- Operates cleaning equipment, utilizing SOP and documentation to record data manually or through identified software applications.
- Responsible for the cleaning of the manufacturing area and following of the appropriate departmental cleaning procedures.
- Ensure that all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations.
- Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of co-workers with all safety policies and procedures at all times.
- Required to use personal protection equipment as needed to perform routine and non-routine duties.
- Ability to climb stairs to perform work on the mezzanine.
- Required to routinely lift 44 lbs.
- Ability to work overtime as required.
- Ability to work in a team environment with minimum supervision and maximum communication.
- Proficient in the use of computers and Microsoft Office tools to communicate shift summaries or follow up through e-mail.
Education and Experience Requirements:
- HS Diploma or GED equivalent required
- Minimum of 0-1 years in a regulated production/operations environment required
- Preferred Associate’s Degree in a related field and a minimum of 1 year in a GMP production/operations facility or 2+ years experience as Process Technician, preferably in the pharmaceutical/biotech industry and Bioworks Certification is desired.
- Knowledge of FDA/cGMP regulations and mechanical background is desired.
- Good documentation practices and attention to detail pursuant to FDA regulation
- Extensive experience in an FDA regulated, GMP environment is preferred
- Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.)
- Interprets data, identifies problems, and formulates proper decisions.
- Expresses ideas clearly (verbal and written) and ability to work from verbal and written instructions, manuals, work orders and specifications.
- Ability to generate and analyze reports, forecast production schedule equipment needs and KPI's dealing with addition, subtraction, multiplication, and division of whole numbers, fractions, and decimals.
- Proficient in the operation and mechanics of high speed, highly automated, production equipment.
- Performs all job functions and responsibilities in a safe and responsible manner.
- Ability to regularly climb stairs to perform work.
- Ability to routinely lift 44 lbs.
- Ability to stand for extended periods of time on shifts that could range from 8-12 hours.
- Ability to operate motorized pallet jacks.
- May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
- May be exposed to strong odors incurred during media production or other operations.
- Lab work is performed wearing various types of PPE which include but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas of Manufacturing.
- Ability to maintain reliable and punctual attendance
- Ability to work overtime as required to support a 24/7 production operation