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Senior Validation Engineer I

Lexington, Massachusetts

Overview

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Senior Validation Engineer I

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Job ID SR0050337 Date posted 06/30/2020 Location Lexington, Massachusetts

Primary Duties

In support of site projects, technical transfers, and ongoing validation maintenance, this position will be primarily responsible for the design, authorship, and execution of qualification studies for the following major systems:

  • Equipment,  Facilities, and Utilities (EFU)
  • Unit operations automation (DeltaV / PLC based systems)
  • Cleaning
  • Sterilization
  • Environmental Monitoring
  • Temperature Controlled Units (Incubators / Cold Storage)

As required, this position will provide technical SME support to Change Controls, Deviations, and CAPAs. The scope of responsibility for this position includes commissioning, qualification, and maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms.Periodic travel may be required to local Takeda operational sites outside of Lexington, MA.

Responsibilities:

30% - 80% of Time:

Design, Author, Execute, and Summarize qualification activities in the following areas:

  • EFU
  • Cleaning
  • Steaming / Autoclave
  • Unit Ops Automation
  • Validation Maintenance

Provide SME input to the following Quality System elements as a representative of the Validation group:

  • Quality Risk Management program
  • CAPAs
  • Change Controls
  • Deviations
  • GMP Investigations

Provide SME input to the following site initiatives as a representative of the Validation group:

  • Technology Transfers
  • Site- and multi-site level Capital projects
  • Site-level Operational Excellence projects
  • Site- and multi-site level Quality System improvements with Validation impact

10% - 20% of Time

  • Participate in partner audits and regulatory agency inspections as a representative of the validation group.
  • Participate in validation group training initiatives to support continuous improvement of validation best practices.

Ongoing

  • Proactively update validation programs guidance to reflect current regulations and trends.

Education and Experience Requirements

Essential:

Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of eight (8) years relevant experience

Desired:

Master’s in Biology, Chemistry, or Chemical Engineering with a minimum of five (5) years relevant experience.

Key Skills, Abilities, and Competencies

Qualified candidates will demonstrate:

  • Relevant work experience with the commissioning and qualification of biotechnology based manufacturing systems
  • Proficiency with formal GMP investigations and root cause analysis
  • Excellent written and verbal communication skills
  • Ability to work independently in a fast paced environment and manage multiple projects and priorities

Complexity and Problem Solving

The successful candidate will:

  • Exercise sound judgment, in cooperation with participating project stakeholders, to ensure that unexpected validation events are assessed and successfully resolved without impact to timeliness or quality standards.
  • Analyze and evaluate validation related risk factors to studies and projects, and escalate issues with proposed solutions to senior management or leadership as necessary. 

Internal and External Contacts

  • In support of ongoing validation responsibilities, the successful candidate will interact regularly with stakeholders from Quality Assurance, Quality Control, Site Engineering, Manufacturing, Facilities, and Operational Excellence.

Other Job Requirements

 The ability to work at all MA BIO OPS site locations as required.  The person in this role will be required to carry an iPhone and be on call, as required, to support validation activities.

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 SR0050337

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