Job Description

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Job Description

Job Title: Manufacturing Lead Technician – IG Visual Inspection and Packaging

Location: Social Circle, GA

About the role:

As the Manufacturing Lead, you will execute all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will participate in both departmental projects and any quality working teams which may be applicable. Under the direction of the supervisor, this position shall manage all activities in the production area. In addition to being accountable and involved in all production processes, you may provide guidance in other areas. You are a delegate to the supervisor and may conduct departmental activities in their absence. You understand the regulations and may make recommendations according to their interpretations. Oversee the successful transfer of new processes/methodologies into the manufacturing area. You will report to the Manufacturing Manager.

How you will contribute:

• Supports all local manufacturing operations.
• Assist supervisor in organizing, scheduling and directing other team members.
• Conduct shift change meeting as needed in lieu of shift supervisor.
• Troubleshoot process problems and respond to process alarms. Main troubleshooting/response person.
• Operate general production equipment for the assigned area.
• Perform Empty Vial and Filled Vial Inspection as needed.
• Main interface with other departments to resolve issues related to equipment, process, and compliance, including quality assurance, maintenance, metrology, and validation.
• Complete relevant paperwork following GDP/GMP guidelines.
• Write, revise and review pertinent documentation as appropriate.
• Participate on Continuous Improvement Teams and may serve in a leadership role.
• Represent the department in cross functional teams as necessary.
• Initiate and/or coordinate other process improvement projects.
• Train and mentor other team members.
• Assist with process/equipment validation and data analysis.
• Assign other project work and/or involvement in teams to team members.
• Perform removal of hazardous/non hazardous waste.

What you bring to Takeda:

• Typically requires high school diploma or GED plus 6+ years of experience or associates’ degree or higher with 4+ years related work experience.
• In-depth process knowledge of related manufacturing techniques and specialties.
• Must have good written and verbal communication skills and understanding of cGMP regulations. Good procedural writing skills.
• Must be able to read and follow detailed written instructions.
• 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.
• Must have demonstrated interpersonal and leadership skills and be able to work effectively and efficiently in a team environment.
• Knowledge of basic chemical and biological safety procedures.
• Must have strong computer skills.

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. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
• Must be able to climb ladders and stairs while wearing special gowning.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment.
• Must be able to work multiple shifts, including weekends. Must be able to work overtime and holidays as required.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• May require immunization before performing work within the manufacturing area.

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.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

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.

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 job. 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.

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