US-MA, Senior Validation Engineer - Automation (DeltaV) and CSV SR0032926-MZ
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:
Develop and assess the following Quality System elements for Validation:
Participate and contribute in design, development, validation strategy, and routine GMP activities:
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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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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