The Manufacturing Technician I will be responsible for cleaning, sanitizing, and monitoring department equipment for proper operation in the manufacturing and associated support areas. Also responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams, which may be applicable. Under the general direction of the lead technician and the overall direction of the Supervisor, this position shall be responsible for Aseptic Cleaning in the Aseptic Filling Complex and surrounding areas. He/She will be required to work in a sterile environment using special gowning. Incumbent must be willing to work overtime as needed.
Essential Job Functions
- Work Schedule: 4 days a week, 10 hours shift (4/10s) or 5 days a week, 8 hours shift (5/8s) or per business needs (Day or Swing)
- Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others.
- Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
- Environmental Demands: The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses.
- Mental Demands: Must be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools.
- High School Diploma or Equivalent minimum;
- Entry to Intermediate years’ experience; some prior experience in a manufacturing setting preferred.
- Proven logic and decision making abilities, critical thinking skills
- Strong written and verbal communication skills are required
- The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action.
Key Accountabilities and Duties:
- Formulate cleaning solutions and sanitize manufacturing core, operate equipment, and monitor production processes and operations as necessary. Record information in documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate
- Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned.
- Supply components, small parts, tubing, etc. to all related areas
- Operate general production equipment (such as mixers, autoclaves, etc.)
- Attain qualification for all assigned tasks and maintain individual training plan
- Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
- Maintain facility and equipment through routine cleaning and sanitization, support 6S programs
- May be required to conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms manufacturing facilities along with Product Process monitoring, Gas testing and Water collection.
- May be required to perform microbial and particulate monitoring of clean rooms throughout the facility; including personnel monitoring of gowns and gloves.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
Job Type: Full-time