Manufacturing Technician II

About the Role

As a Manufacturing Technician II at Takeda, you'll help support safe, reliable pharmaceutical manufacturing by operating production equipment, executing manufacturing processes, and maintaining compliance with current Good Manufacturing Practices (cGMP) and environmental health and safety requirements. You'll apply your technical knowledge to troubleshoot process issues, support equipment operations, maintain accurate manufacturing documentation, and contribute to continuous improvement initiatives. You'll also help strengthen team performance by sharing technical knowledge, supporting training, and assisting with the introduction of new technologies and procedures into manufacturing. Reporting to the Manufacturing Supervisor, you'll work collaboratively with your team to maintain product quality, operational efficiency, and a safe manufacturing environment.

Operating Hours: Sunday-Thursday from 10:00pm-6:30am

How You Will Contribute

• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems and other production equipment, including autoclaves and COP washers.
• Assemble valve assemblies and filter carts and support other production preparation activities.
• Execute manufacturing activities and document production operations using Electronic Batch Management (EBM) and other applicable systems.
• Perform routine cleaning of production rooms and equipment to maintain required GMP conditions.
• Collect samples using appropriate aseptic techniques and follow established procedures to protect product quality.
• Troubleshoot process issues, respond to equipment alarms, and help identify and resolve technical problems that may affect manufacturing operations.
• Complete, review, and revise manufacturing documentation, including routine updates and new or more complex procedures when appropriate to the role.
• Follow Good Documentation Practices (GDP), GMP requirements, environmental health and safety procedures, and other applicable site standards.
• Receive and distribute supplies to production areas as needed to support manufacturing activities.
• Participate in continuous improvement teams and contribute ideas to improve safety, quality, consistency, and operational efficiency.
• Train and mentor team members by demonstrating proper procedures and sharing technical knowledge.
• Support the transfer of new technologies and manufacturing procedures into production, as needed.
• Perform other duties as assigned.

Qualifications

• A high school diploma or GED plus 2+ years of related experience, or an associate degree or higher plus 1+ year of related work experience, is typically required.
• Knowledge of manufacturing procedures and cGMP requirements is required.
• Familiarity with production equipment such as CIP/SIP systems, autoclaves, COP washers, and related pharmaceutical manufacturing equipment is preferred.
• The ability to follow detailed written procedures and complete accurate manufacturing documentation is required.
• The ability to troubleshoot manufacturing process issues, respond to alarms, and recognize when additional technical support is needed is required.
• Knowledge of basic chemical and biological safety practices is required.
• Strong computer skills, including familiarity with Microsoft Word and Excel, are required.
• Good written and verbal communication skills and the ability to work effectively as part of a team are required.
• The ability to share technical knowledge and support the training of other team members is required.
• A commitment to safe work practices, continuous improvement, and maintaining product quality is required.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we follow strict requirements in our manufacturing facilities to protect product quality, employee safety, and regulatory compliance. In this role, you may:

• Work multiple shifts, including weekends and holidays, and work overtime or outside standard hours as required by manufacturing needs.
• Work in cleanrooms and controlled manufacturing environments requiring special gowning and personal protective equipment (PPE).
• Wear required protective clothing and equipment, which may include safety garments and other PPE based on the work area and task.
• Follow applicable manufacturing-area restrictions on makeup, jewelry, contact lenses, nail polish, and artificial fingernails.
• Lift approximately 25–50 pounds, stand for extended periods during a 10–12-hour shift, and frequently lift, carry, push, pull, or move objects and perform repetitive motions.
• Work indoors in conditions that may include cleanrooms, cold or wet areas, and cool or hot storage environments.
• Some duties may require working in confined areas.
• Undergo immunization if required before performing certain work within the manufacturing area.
• Follow site safety procedures, applicable GMP requirements, and required training and documentation practices.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.