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Job Title: Manufacturing Training Coordinator

Location: Cambridge, MA (USA)

About the role:

Reporting to the Manufacturing Support Manager, the training coordinator is responsible for the following:

• Assess training effectiveness. Work with training and quality groups to improve training materials and curriculum.
• Assign appropriate curriculum to new employees and provide a detailed overview of the manufacturing portion of the training program.
• Hands-on training of manufacturing staff.
• Present training process during audits and inspections. Accountable for implementation of regulatory commitments.
• Provide detailed qualification status by training reports and identify any gaps or opportunities.
• Perform qualification of manufacturing personnel on important operations including aseptic technique and swab sampling.
• All Internal Manufacturing, Training, Materials Management Facilities Management and Health, Safety & Environment with limited exposure to support groups (Validation, Quality Control).
• Will require minor external contact with equipment and supply item vendors.
• In collaboration with manufacturing supervisors schedule training events to train manufacturing personnel.
• You will be responsible for technical and operational improvements.
• Support quality systems and implement action items stemming of CAPAs and Change Controls.

How you will contribute:

70% of Time

Training:

• Recommend/Implement process or safety improvements.
• Train manufacturing personnel on manufacturing operations and Lean manufacturing systems. Maintain and revise training material to support training.
• Ensure documentation is complete, reviewed and meet good documentation practices.
• Help identify training needs.

20% of Time

Quality:

• Communicate any quality issues/concerns to Supervisor and QA.
• Support deviation investigations as an SME.
• Complete action items for GMP investigations and CAPA's.
• Support regulatory inspections and commitments.
• Revise training material.

10% of Time

People:

• Be a role model (Lead by Example).
• Be a resource/SME for staff.
• Use safe work practices and behaviors.
• Ensure staff compliance with all relevant SOPs, BR, FP and safety guidelines during training.
• Provide feedback on staff's performance.

What you bring to Takeda:

• Stooping or bending to check or trouble-shoot equipment operations.
• Flexibility to work according to the production schedule. We may ask you for weekend, and overtime work.
• Work around chemicals (alcohols, acids & bases).
• Stand for 6 hours in a production suite.
• Climb ladders and work platforms.
• Lift equipment requiring up to 25-50 lbs. of force.
• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department.
• Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience. Experience with systems such as SAP, LIMS and TrackWise and lean operating principles.
• Operational knowledge of upstream or downstream manufacturing including Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters etc.
• Gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

What Takeda can offer you:

• Professional training opportunities
• Community Outreach Programs and company match of charitable contributions
• Generous time off for vacation and the option to purchase additional vacation days
• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Family Planning Support
• Tuition reimbursement
• Health & Wellness programs including onsite flu shots and health screenings

Important Considerations:

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. You may:

• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

This posting excludes Colorado applicants.

#GMSGQ #ZR1 #LI-MA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Cambridge - Alewife - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time