Posted to MedZilla on 8/25/2019

Takeda Pharmaceuticals

US-GA, IG Filling and Packaging Operations Analyst SR0038497-MZ


Primary Duties

The position will support the development of a plasma processing facility that will bring the company additional capacity for fractionation, purification, and fill and finish for its biologic medications. This position will report to the Associate Director, Head of IG Filling and Packaging Manufacturing and support both the IG Filling and IG Packaging manufacturing departments.


  • Responsible for the management of all manufacturing procedure documents (SOPs, job aids, forms, etc.). Successful candidate will manage and prioritize the list of document improvements.
  • Responsible for the authoring and revising on manufacturing procedure documents (SOPs, job aids, forms, etc.) to support the continuous improvement environment and ensure the success of the manufacturing team. Successful candidate may delegate some document updates, but will be the primary author and final reviewer for all documents.
  • Liason to the Document control team. Successful candidate will be responsible for routing all documents for approval in the appropriate document management system.
  • Drive manufacturing deliverables (documents, small projects, blue belt investigations, etc.) to ensure successful commercial operations.
  • Accountable for creation, distribution, and/or delivery of activities, documents, tools, or items that set the team up for success , such as communication packages.
  • As needed for the department, support any Environmental, Health, and Safety (EHS) CAPAs or evaluations.
  • Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls. Successful candidate will have Trackwise access to own and deliver on action items.
  • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding / problem solving capability.
  • Responsible for collecting and organizing processing data (including cycle time, reject rates, line efficiencies (OEE)) and preparing appropriate documentation, including weekly presentations or reports
  • Works closely with process owners /SMEs to define and develop improvements to procedures and workflow to create the best known standard way
  • Serve as point of contact for department process information
  • Serve as backup for training as required.

Education and Experience Requirements

  • Bachelor's degree, preferably in science, engineering or other related technical field with some related experience or
  • High School Diploma plus 4+ years of related experience

Key Skills, Abilities, and Competencies

  • Strong problem-solving and analytical skills are required.
  • Possess knowledge of core manufacturing principles and support systems.
  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
  • Self-driven individual that requires minimal supervision.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
  • Prefer experience in Track-wise system.
  • Prefer experience in Automation Control Systems, EBM (Electronic batch Record), PI Historian.
  • Prefer knowledge of Lean Six-Sigma methodology.

Other Job Requirements

  • May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry).
  • May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. Company provides PPE.
  • May be required to work weekends, evenings, off-hours, extended periods of time.

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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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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