Manufacturing Lead Operator

Job Description
About the role:

The Manufacturing Lead Operator is responsible for executing processes in production while strictly adhering to cGMP, environmental health and safety guidelines, and any other related regulations which could apply. Under the overall direction of the supervisor, this person must aid in establishing daily shift priorities, and then communicate and delegate tasks to safely accomplish those priorities. They are expected to exercise proper judgement with regards to Safety, Quality, and Production decisions.

They must apply their subject matter expertise and their understanding of the capabilities and performance of their team members to quickly assess critical issues. They must be able to effectively escalate all relevant information and be prepared to recommend appropriate actions. They are expected to communicate all critical information to their respective teams as well as relay the appropriate shift-to-shift updates through all applicable communication tools and at shift handoffs.

In addition to being fully accountable in production processes, this person may help problem solve in other functional areas. They are expected to participate in departmental projects and quality working teams. The incumbent shall act as a delegate to the supervisor and may conduct departmental activities in their absence. They fully understand the regulations and may make recommendations according to their interpretations.

They have a high level of technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment, and they may assist during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to serve as a mentor and set the example for all team members since their team will interpret that behavior as acceptable.

• 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 may include:
  Centrifuges, Filter Presses, Ultrafiltration, Tangential Flow Filtration and Nanofiltration systems, CIP/COP, Chromatography 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.

• Initiate and/or coordinate other process improvement projects.

• Drive performance of team members by promoting a positive work environment emphasizing Patient, Trust, Reputation, and Business.

• High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience.

• Must have demonstrated interpersonal and leadership skills and be able to lead a team effectively.

• Demonstrated record of exercising proper judgment with regards to Safety, Quality, Compliance, and Production decisions.

• In-depth process knowledge of related manufacturing techniques and specialties.

• Advanced automation experience using Delta
  
  V, 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 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.

• 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.

• At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment…