Shire Manufacturing Technician II- 1st Shift Sun-Wed in Lexington, Massachusetts

Primary Duties

With general supervision the individual will perform routine and critical manufacturing operations,

including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep

areas. Operates production equipment according to SOPs for the production of clinical and/or

commercial products.

Responsibilities

80%

This individual will carry out cGMP manufacturing operations utilizing

Standard Operating Procedures (SOP), Batch Records and Form

Preps. Primary responsibilities include the following:

  • Troubleshoot and resolve process related issues

  • Initiate and document minor deviations

  • Execution of critical and routine production operations

  • Perform Batch Record, Log Book and Form Prep requests

  • Enter data in the Laboratory Information Management System (LIMS)

  • Record data into log books

  • Review log book data

  • Sample preparation and testing

  • Propose document revisions

  • Complete required training on time

  • Carry out work in a safe manner, notifying management of safety issues and risks

10%

This individual will manage equipment and support facility related

projects by:

  • Assembly and disassembly of process equipment

  • Perform scheduled cleaning of equipment

  • Perform standardization of equipment

  • Support change over activities

  • Execution of equipment and process qualifications as well as validation

10%

Staff Technical Training and Development

  • Meet and maintain training requirements

  • Develop and maintain personal development plan

  • Provide annual performance self assessment on development plan

Education and Experience Requirements

Normally requires a high school diploma and 2-4 years related industry experience or an

Associates Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing

experience. Biotech Certificate preferred

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/OFCCPEEOSupplementFinalJRFQA508c.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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.