Shire Validation Engineer II in Cambridge, Massachusetts
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:
Facilities, Equipment, and Utilities (FEU)
Unit Operations Automation (PLC based systems, Delta V, etc.)
Environmental Qualification and Monitoring
As required, this position will provide technical SME support to change controls, deviations, and CAPAs.
The scope of responsibility for this position includes commissioning and 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 Shire operational sites outside of Cambridge, MA.
Design, Author, execute, and summarize qualification activities in the following areas:
Steaming / Autoclave
Unit Ops Automation
Provide SME input to the following Quality System elements as a representative of the validation group:
Quality Risk Management program
Provide SME input to the following site initiatives as a representative of the validation group:
Site and multi-site level capital projects
Site level Operational Excellence projects
Site and multi-site level Quality System improvements with validation impact
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.
Proactively update validation programs guidances to reflect current regulations and trends.
Education and Experience Requirements:
Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of three (3) years relevant experience.
Other Job Requirements:
The ability to work at all MA site locations as required. The person in this role will be required to carry an iPhone and be on call as required to support process 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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, 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 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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.