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Manufacturing Technician 1

Lexington, Massachusetts

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Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

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Manufacturing Technician 1

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Job ID SR0056814 Date posted 11/20/2020 Location Lexington, Massachusetts

This position reports to Nights, 6:00 pm – 6:30 am, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.

With direct supervision the Manufacturing Technician I will perform routine manufacturing operations for the production of clinical and/or commercial products. Operates production equipment according to SOPs in their assigned areas.

Responsibilities:

The Manufacturing Technician l will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records, and Form Preps.

Primary responsibilities include:

80%

  • Execution of activities in support of production
  • Perform requests and execution of GMP documentation
  • Enter data in the Laboratory Information Management System (LIMS), MODA, and or other business systems
  • Sample preparation and testing
  • Identify changes needed to documentation
  • Complete required training on time
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Participate in tiered visual management system

10%

  • Manage equipment and support facility related projects by
  • Recognize issues and escalate to senior staff
  • Perform scheduled cleaning of equipment
  • Perform standardization of equipment
  • Support change over activities
  • Assist in the assembly and disassembly of process equipment

10%

  • Staff Technical Training and Development
  • Maintain training requirements
  • Develop and maintain personal development plan
  • Provide annual performance self-assessment on development plan

Requirements

Minimum:

  • High School Diploma or an Associate degree in Life Sciences/Engineering field
  • 0 - 2 years related industry experience

Preferred:

  • Biotech Certificate

Other Job Requirements

  • Travel to other MA Bio Ops sites may be required
  • Valid license may be required for travel between sites
  • May require weekend or holiday off shift support as needed

Key Skills, Abilities, and Competencies

  • Little to moderate understanding of general job aspects and some understanding of the detailed aspects of the job.
  • The individual should have the ability to perform functions such as: Following written instruction in the form of Batch Records, Form Preps, Technical Protocols, and Procedures
  • Possess excellent communication and troubleshooting skills
  • Familiar with current Good Manufacturing Practices
  • Basic documentation and computer skills
  • Will work holidays and overtime as required
  • May be required to adjust work schedule to meet production demands
  • Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes
  • Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
  • Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force
  • Ability to stand up to 6 hours in a production suite
  • Ability to climb ladders and work platforms
  • Stooping or bending to check or trouble-shoot equipment operations
  • Ability to work around chemicals (alcohols, acids & bases)
  • Familiarity with aseptic technique

Complexity and Problem Solving

  • Works on assignments that are semi-routine in nature where ability to recognize deviations from accepted practice is required
  • Receives assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives
  • Accomplishes tasks mainly through direct operation of cGMP activities
  • Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff

Internal and External Contacts

Internal

  • All Internal Manufacturing, Materials Management, Technical Operations and Facilities Management with limited exposure to support groups (Validation, Quality Control, Process Development and Health, Safety & Environment (EHS))

Vendor

  • May require interaction with equipment, technical and supply item vendors

Please be aware that this position is considered “Essential Personnel.” This means that in the case of inclement weather (e.g. snowstorm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary. To ensure “Essential Personnel” are safe during inclement weather situations Shire may provide lodging,

shuttle service, and food (depending on the severity and duration of the inclement weather event).

These details will be provided by management prior to any potential inclement weather situation.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

Job ID SR0056814

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