Lead Manufacturing Technician

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As the Lead Manufacturing Technician you will execute all processes in production while strictly adhering to cGMP environmental health and safety guidelines and any other related regulations which could apply. You will fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the supervisor this position shall be responsible for the hands-on execution of all activities in the production addition to making routine revisions to documents you will rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. The position requires technical and administrative competence to organize and lead production activities including demonstrating leadership in cGMP compliance and environmental health and safety skills.

This role is a day shift 5:00am 5:30pm in a 2-2-3 work schedule configuration.

• Lead training efforts and mentoring for manufacturing tech progression from level 1-3

• Conduct safety Gembas and provide coaching daily to ensure technicians are adhering to proper ergonomic techniques.

• Support all local manufacturing operations.

• Demonstrate proficiency in electronic systems such as (EBM JDE etc.)

• Operate general production equipment (such as Filling Inspection & Packaging equipment).

• Ensure relevant paperwork following GDP/GMP guidelines.

• Manually clean all portable equipment and small parts.

• Participate on Continuous Improvement Teams.

• Receive and distribute supplies into the production area as necessary.

• Monitor daily cleaning of the production area to maintain in GMP fashion.

• Assemble and operate filtration systems.

• Ensure all components necessary for Manufacturing are prepped and ready to meet schedule adherence in addition to setting up incoming shift for success.

• Troubleshoot process & equipment problems in a timely manner to minimize Manufacturing downtime.

• Coordinate with other groups such as maintenance/metrology to ensure preventative maintenance is done per plan.

• May perform other duties as assigned.

• Must be able to speak read write and follow detailed written and oral instructions in English.

• Must have excellent written and verbal communication skills and understanding of cGMP regulations.

• Exceptional procedural writing skills required.

• Skilled with pharmaceutical production equipment including but not limited to autoclave.

• Must be able to apply quantitative analysis to analyze process performance.

• Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.

• Highly effective interpersonal skills and be able to work effectively and efficiently in a team environment.

• Knowledgeable of chemical and biological safety procedures.

• Good computer skills.

• High school diploma or GED required; Associate degree or higher preferred.

• Minimum 6 years of manufacturing experience in a regulated environment or 4 years of related experience with an Associate degree or higher.

• Previous experience in pharmaceutical biotechnology medical device or other regulated manufacturing environments preferred.

• Demonstrated leadership experience including mentoring coaching or supporting production teams in a lead or supervisory capacity.

• Strong understanding of cGMP/GDP regulations and manufacturing documentation practices.

• Hands-on experience operating and troubleshooting pharmaceutical manufacturing equipment including filling inspection packaging filtration or autoclave systems preferred.

• Ability to support and coordinate manufacturing operations in a fast-paced production environment while maintaining a strong focus on safety quality and schedule adherence.

• Strong problem-solving troubleshooting and decision-making skills with the ability to minimize operational downtime.

• Effective written and verbal communication skills with the ability to work collaboratively across Manufacturing Maintenance Quality and Engineering teams.

• Experience utilizing manufacturing and business systems such as EBM JDE or similar electronic systems preferred.

• Proficient computer skills including Microsoft Office applications.

• Strong organizational interpersonal and leadership skills with the ability to train and develop team members.

• Knowledge of chemical and biological safety procedures and safe manufacturing practices.

• Ability to perform quantitative analysis and interpret production/process data to support operational improvements.

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 this role you may:

• In general the position requires a combination of sedentary work and walking around observing conditions of the facility.

• Must be able to carry up to 30lbs lift up to 30lbs push/pull up to 30lbs (with assistance of material handling equipment).

• Must be able to stand and/or walk for an extended period over an 812-hour shift between rooms and across the site.

• May require bending twisting reaching overhead and/or squatting motions to perform certain tasks.

• Repetitive motions with hands wrists turning head bending at knees and waist.

• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and/or contacts.

• Indoor working conditions and exposure to loud noises that requires hearing protection.

• Will work around moving equipment and machinery.

• May be required to work in confined spaces/areas.

• Some Clean Room and/or cool/hot storage conditions. (Applies to roles in Filling Department only).

• May be exposed to and must not be allergic to cephalosporin. (Applies only to product touch roles remove for all other roles).

• May 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.

• Will need to remove all make-up jewelry contact lenses nail polish and/or artificial fingernails while in the manufacturing environment.

• May work in a cold hot or wet environment.

• May work around chemicals such as alcohol acids buffers and Celite that may require respiratory protection.

• May require immunization before performing work within the manufacturing area.

• Must be able to work on multiple shifts including weekends and holidays to support a 24/7 manufacturing operation as needed.

• Must be able to work a 12-hour shift (5:00am 5:30pm) in a 2-2-3 rotation.

• Must be able to work non-traditional work hours including weekends and holidays as needed.

• Must be able to work overtime as required.

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.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Job Exempt