Shire Validation Engineer in Lexington, 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 with Honeywell, Delta V, and PLC based systems
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 Lexington, MA.
Varies, 30% - 80%
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
Varies, 10% - 20%
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 8 years relevant experience or Master’s in related field with a minimum of 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, Facilties Engineering, and Operational Excellence.
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.
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, 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.