The Manufacturing Tech IV is responsible for aiding in 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 and Manufacturing Lead, this position shall aid the Manufacturing Lead in the execution of all activities in the production area. When the Manufacturing Lead is absent, the Manufacturing Tech IV will be fully accountable and involved in all production processes when in an interim Lead Operator role. Alternatively, he/she will utilize special skills/tasks (Preventive Maintenance, Mechanical Troubleshooting and repair, etc.) in addition to the manufacturing responsibilities described in this job description. He/she may problem solve in other functional areas. When acting as an interim Lead Operator, the incumbent acts as a delegate to the Supervisor/Manufacturing Lead 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 Tech IVs are expected to set the example for all other Takeda 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 Takeda while promoting Takeda'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, Nano-filtration 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.
- Troubleshoot process problems and respond to process alarms.
- May assist Manufacturing Lead and Supervisor with managing manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor.
- May serve as main interface with other departments including maintenance, metrology, engineering and validation.
- May assist Supervisor/Manufacturing Lead in organizing, scheduling and directing other team members.
- 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.
- May create and update daily production schedules (Fractionation, Albumin, AHF-M and buffer prep) for manufacturing.
- May interface with production scheduling tools (Excel and/or other system), DeltaV, EBM and other supporting tool.
- May perform preventive maintenance of critical manufacturing equipment
- Write and/or revise preventive procedures as needed
- Provide a moderate level of troubleshooting, diagnostic, and repair of critical manufacturing equipment
- May execute sanitization of department specific critical systems
- May generate and execute Maintenance Work Orders using JDEdwards
- May perform removal of hazardous waste.
- 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 may be required.
- Experience in DeltaV, EBM, scheduling software or similar systems.
- Must be able to complete tasks with minimal supervision, prioritize multiple tasks, and manage time effectively.
- Basic knowledge of instrumentation and mechanical such as controllers, indictors, control valves, PLC, analyzers, sensors, pumps, etc.
Education and/or experience
- Requires high school diploma or GED with 4+ years related work experience, or AA or higher with 2+ years related work experience. Mechanical, electrical, instrumentation, or control systems repair experience preferred for mechanical special skills role.
- 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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.Equal Employment OpportunityShire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdfPay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf