Posted to MedZilla on 10/13/2019

Takeda Pharmaceuticals

US-GA, Manufacturing Trainer, Fractionation Department SR0041078-MZ


Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

The position will support the development of a new, state-of-the-art plasma processing facility that will bring Shire additional cGMP capacity for fractionation, purification, filling, and packaging for its biologic medications.

The Manufacturing Trainer position is responsible for developing trainees into qualified associates following company procedures. The trainer role will execute production activities in addition to other facility production training support, as needed. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.


  • Provide on the job training and assisting with e-learning requirements.
  • Analyze training needs, monitor training compliance
  • Provide constructive feedback and coaching to associates.
  • Perform hands-on execution of manufacturing operations to support production schedule as needed.
  • Identify training gaps and developing a strategy to close them.
  • Anticipate problems or opportunities and implement proactive solutions.
  • May be required to write or revise SOP s, Job Aids, Knowledge Assessment and Skills Assessments.
  • Contribute toward authoring SOPs, Job aids, and Structured on the Job Training (SOJT) associated to manufacturing processes.
  • Provide assistance to other Associates with SOJT and E-Learning requirements.
  • Manage and execute training interventions designed to solve specific training problems for either individuals or groups (Investigations, CAPA, Protocols)
  • May be required to develop specific training programs to help associates learn sustain and/or improve their job skills.
  • Support the implementation of Kaizen, Kanban and 5S systems to assist from CQV to Full production environment. Inform department managers of continuous improvement opportunities.
  • Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS) through all manufacturing associates and production engineers. Understand and follow Job Hazard Analysis (JHA) packets.
  • Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.


  • Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.
  • Understanding of supplier/customer process streams and interdependencies, and be able to work on cross functional teams.
  • Must have customer services and leadership attitude to take ownership of any maintenance related problem.
  • Must be able to read, write and converse in English.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Must have good interpersonal skills, be able to work effectively and efficiently in a team environment and provide constructive feedback and coaching to other Associates.
  • May require immunization before performing work within the manufacturing area.
  • Must demonstrate importance of working in a regulated environment.
  • Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet.
  • Must have and display the following personal attributes: Integrity, trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.


  • Must be able to lift, push, pull and carry up to 50 lbs.
  • 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, contact lenses, nail polish or artificial fingernails may be worn in the work environment.
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.
  • Will work around chemicals such as alcohol that may require respiratory protection.
  • May be required to work or be assigned to shifts as needed.
  • Must be able to work weekends or overtime as required.
  • Inside working conditions.
  • Some clean room and cool/hot storage conditions.

Education and Experience

  • Experience in a regulated environment desirable.
  • Must be qualified in at least one process function in Fractionation.
  • High school diploma or equivalent required. Associate degree preferred.
  • Must have working knowledge of GxP and training principles.
  • Minimum 5 years of experience.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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EEO is the Law Supplement -

Pay Transparency Policy -

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.