This position reports to Grave (3) shift. This shift schedule is Monday to Friday 10:00 PM to 6:30 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
This position is 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 manufacturing lead operator and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. Activities include manual tasks and operation of automated equipment. He/She has sufficient technical and administrative competence to initiate minor revisions to existing documents, to troubleshoot simple existing procedures, and to contribute to continuous improvement initiatives. Essential Duties and Responsibilities
- Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
- Support all local manufacturing operations.
- Complete relevant paperwork following GDP/GMP guidelines.
- Perform hands-on execution of manual and automated manufacturing operations. Equipment includes but is not limited to: Centrifuges, Filter Presses, Ultrafiltration systems, CIP/COP, Nanofiltration Skids, Chromatography Columns and material handling devices. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, room cleaning, equipment assembly/disassembly, transfer panel connections, titrations and other activities.
- Receive and distribute supplies into the production area as necessary.
- Perform removal of hazardous waste.
- Troubleshoot minor process problems and respond to process alarms.
- Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor.
- Participate in the training of team members on the manufacturing floor.
- Participate in the revision and review of pertinent documentation as appropriate.
- Participate in Safety and Continuous Improvement Teams.
- May perform other duties as assigned.
Education and/or experience
- General working knowledge of related manufacturing techniques and specialties.
- Automation experience using DeltaV, Electronic Batch Management, PLC, etc.
- Familiarity with pharmaceutical production equipment including but not limited to centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
- Must have good communication skills (both verbal and written) and understanding of cGMP regulations in a pharmaceutical manufacturing environment.
- Must be able to read and follow detailed written procedures.
- Proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of basic chemical and biological safety procedures.
- Good computer skills.
Requires high school diploma or with 1-2 years related experience. Physical Demands
- Must be able to lift, push, pull and carry up to 50 lbs.
- Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.
- Must be able to climb ladders and stairs while wearing special gowning.
- May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
- Will work in a cold, wet environment.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required. (only for non-exempt positions)
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.