This position reports to Grave (3) shift. This shift schedule is Monday to Friday 10:00 PM to 6:00 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
The Manufacturing Lead Operator 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 overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas.
The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. He/She fully understands the regulations and may make recommendations according to their interpretations. He/She has sufficient technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment and assists during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to set the example for all other Shire employees as his/her team members observe the behavior of their leadership and interpret that behavior as acceptable. He/She must display the appropriate conduct, compliance, cleanliness, and culture of Shire while promoting Shire's primary leadership behaviors. Essential Duties and Responsibilities
- Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
- 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 process problems and respond to process alarms.
- Act as the primary manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor.Main interface with other departments including maintenance, metrology, engineering and validation.
- Assist supervisor in organizing, scheduling and directing other team members.
- May act as a delegate to the supervisor in their absence.
- Participate in the training and mentoring of team members on the manufacturing floor.
- Write, revise and review manufacturing related documents as appropriate.
- Participate in Safety and Continuous Improvement Teams and may serve in a leadership role.
- Initiate and/or coordinate other process improvement projects.
- Drive performance of team members by promoting a positive work environment emphasizing respect, responsiveness, and results.
Education and/or experience
- In-depth process knowledge of related manufacturing techniques and specialties.
- Advanced 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).
- Experience operating material handling equipment such as pallet jacks and forklifts.
- Must have strong communication skills (both verbal and written) and a robust understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Must be able to read and follow detailed written procedures.
- Must be able to apply quantitative analysis to analyze process performance.
- Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Must have demonstrated interpersonal and leadership skills and be able to lead a team effectively.
- Knowledge of basic chemical and biological safety procedures.
- Must have good computer skills including knowledge of Microsoft Office applications. Experience with applications such as LIMS and JD Edwards preferred.
Requires high school diploma and a minimum of 6 years related experience, or Bachelor with minimum of 4 years related experience. College degree in Science or Engineering discipline strongly preferred. 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.