About the role

Responsible for scheduling, conducting, and documenting Structured-On-The-Training (SOJT) and Instructor Led Training (ILT) from basic to complex learning activities. Participate in employee performance improvement initiatives and collaborate with Operations to increase effectiveness of job specific GMP training. Collaborate with Subject Matter Experts (SME's) within multiple process areas, to process project working and continuous improvement teams. Lead training team members in meeting goals in absence of Training Supervisor.

How you will contribute

• Collaborate with shift Supervisors to develop and implement learning plans.
• Schedule, and provide hands on training on core manufacturing tasks, SOP's, and equipment operation per training plan.
• Conduct periodic operation audit sessions for employees evaluating compliance (including investigations) effectiveness of training, and comprehension of training.
• Support development of cross-training plans for assigned areas to support their goals and objectives.
• Deliver New Employee Orientation training session.
• Evaluate, review, and revise/or create SOPs following periodic requirement.
• Maintain training matrices and training plans to identify training gaps, track status and workforce levels.
• Assign training roles with current Learning Management System (LMS) to employees based on current need and ensure personnel training requirements are met.
• Create training materials that supplement associated SOPs and process for assigned areas.
• Demonstrate mastery of applicable process concepts, technical content, course curriculum and training methodologies.
• Lead and mentor the L&D team members.
• Collaborate with management, cross-site personnel, and internal/external resources to develop and implement new training and improve the training program.
• Participate in regulatory inspections/audits.

What you bring to Takeda

• Requires minimum high school diploma or GED. 6 years of experience or AA or higher with 4 years related work experience.
• (Preference) In-depth manufacturing process knowledge, including proficient knowledge and qualification in one or more processes, intermediate suspension, centrifuge operation, chromatography, COP, CIP, filtration, UF/DF, filter press operation and facility/equipment cleaning.
• Solid knowledge in Good Manufacturing Practices and Good Data & Documentation Practices (GDDP).
• Experience training people in a regulated working environment. This may include the technical aspects surrounding theory and application.
• Proficient in Microsoft applications such as Word and Excel.
• Working knowledge of applicable SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs. Familiarity with cGMP audit process, exception management, quality systems, and interpretation of regulations.
• Able to solve technical, compliance, or operational problems as assigned.
• Experience of project management.
• Expertise in applying LEAN or Six Sigma principles and continuous improvement methodologies is a plus.
• Must be proficient in written and oral English.

Important Considerations

• Must be able to lift, push, pull and carry up to 50lbs.
• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.
• Will work in controlled environments requiring special gowning.
• Will 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 in a cold and wet environment.
• Must be able to work multiple shifts, including weekends.
• Can work overtime.
• May work in a confined area.
• Some Clean Room and cool/hot storage conditions.

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.