Shire Senior Validation Engineer - Automation and CSV in Lexington, Massachusetts
This position will be responsible for executing and reviewing control system and process automation validation activities and ensuring adherence to data integrity principles and best practices for Takeda including projects associated with PCS/PAS, DeltaV, BMS, CMS, Simca, Statistica, OSI PI and other Takeda automation systems.
Technical duties include writing and executing validation documents, reviewing and analyzing data, adhering to domestic and international GMP regulations, and incorporating continuous improvements into validation activities and policies, and participating in regulatory inspections.
Individual will lead and advise full time and contingent staff on validation strategies and principles and provide support for and interact with regulatory authorities during inspections.
The scope of responsibility encompasses the product life cycle for existing commercial pharmaceutical and biopharmaceutical products as well as emerging products and platforms.
Occasional travel may be required for business meetings with vendors/contractors and to stay current with professional development. Routine travel required to local Takeda operational sites.
Write, execute, summarize validation activities in the following areas:
Validation document control and archival program
Develop and assess the following Quality System elements for Validation:
Quality Risk Management program
Participate and contribute in design, development, validation strategy, and routine GMP activities:
Provide technical input to strategy/philosophy for validation activities
Represent validation during tech transfer activities as required.
Represent validation during site GMP activities and participate on cross-functional teams
Identify opportunities for continuous improvements, participate in the deployment of best practices, pro-actively update validation programs to reflect current regulations and trends.
Participate in partner audits and regulatory agency inspections for Validation. Author and review sections of regulatory filings and annual product quality reviews.
Train other Takeda staff on validation equipment and protocols
Education and Experience Requirements
Minimum requirements include a Bachelor's degree in a technical discipline, preferably engineering or biological sciences and a minimum of 10 years pharmaceutical and/or biopharmaceutical industry experience. Experience with authoring validation protocols and reports are strongly desired. Understanding GMP regulations, quality systems, and ICH guidelines are preferred. An advanced degree (masters) or industry certification is a plus.
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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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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.