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Senior Manufacturing Specialist

2 months ago


Social Circle, Georgia, United States Takeda Pharmaceutical Full time
About the Role:

We are seeking a highly skilled and experienced Senior Manufacturing Technician to join our team at Takeda Pharmaceutical. As a key member of our manufacturing operations team, you will be responsible for executing all production processes while ensuring compliance with cGMP, environmental health and safety guidelines, and other relevant regulations.

As a Senior Manufacturing Technician, you will be accountable for all production processes, provide guidance to other departments, and serve as a delegate to the supervisor. You will also be responsible for managing the successful transfer of new processes and methodologies into the manufacturing area.

This is a full-time position that requires a strong understanding of manufacturing operations, quality control, and regulatory compliance. You will work closely with our manufacturing supervisor and other team members to ensure the smooth operation of our production processes.

Key Responsibilities:
  • Execute all production processes in compliance with cGMP, environmental health and safety guidelines, and other relevant regulations.
  • Provide guidance to other departments and serve as a delegate to the supervisor.
  • Manage the successful transfer of new processes and methodologies into the manufacturing area.
  • Assist in the development and implementation of new manufacturing processes and procedures.
  • Collaborate with the manufacturing supervisor and other team members to ensure the smooth operation of production processes.
  • Ensure accurate generation of process documentation and review documentation.
  • Resolve issues related to equipment, process, and compliance.
  • Investigate process problems and provide documentation.
  • Participate in Continuous Improvement Teams and may serve in a leadership role.
  • Train other team members and monitor training for newer team members.
  • Help with process/equipment validation and data analysis.
  • Assign other project work and involvement in teams to team members.
  • Represent the department in teams.
  • May perform other duties as assigned.
Requirements:
  • High school diploma or GED plus 4+ years of related work experience or associates' degree or higher and 2+ years related work experience.
  • Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.
  • Knowledge of laboratory and pharmaceutical production equipment including: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
  • Ability to apply quantitative analysis to analyze process performance.
  • Proficient in different mathematical disciplines and able to work with both metric and USA standards of measurement.
  • Good procedural writing skills.
  • Knowledge of chemical and biological safety procedures.
  • Knowledge of Microsoft Word and Excel.
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 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.
  • Work in a cold, wet environment.
  • Work multiple shifts, including weekends, or be asked to work supplemental hours.
  • Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
  • Will carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
  • Will stand for extended periods of time over an entire 8 or 12-hour shift.
  • Will climb ladders and stairs while wearing special gowning.
  • May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.
  • 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.
  • May work in a confined area.
  • Some Clean Room and cool/hot storage conditions.
  • May require immunization before performing work within the manufacturing area.
About Takeda:

Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed 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.

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-Onsite

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:

USA - GA - Social Circle - Hwy 278

U.S. Hourly Wage Range:

$35.43

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.