Shire Global Calibration Leader in Lexington, Massachusetts

Primary Role :

Leads global calibration programs and projects. Recognized as a technical and compliance subject matter expert in instrumentation and calibration. Responsible for development, implementation and on-going support of programs, processes, and procedures to ensure business and compliance objectives are met.

Responsibilities :

  • 40%: Operational Direction: Provides operational direction for calibration program. Document owner for global calibration procedures. Subject matter and compliance expert for instrumentation and calibration topics. Business owner for calibration computerized maintenance management systems.

  • 20%: Global Engineering Leadership: Leads development and standardization of the global calibration program with focus on increased harmonization, efficiency and compliance. Collaborates with stakeholders to optimize the calibration program and to resolve maintenance related inspection observations with global implications.

  • 20%: Thought Leadership: Fosters environment for knowledge sharing and development within the engineering organization. Ensures alignment of global calibration process with current global GMP requirements. Identifies best practices, promotes sharing and adopting, and incorporates into global standards as appropriate.

  • 20%: Customer Collaboration: Effectively collaborates with customers to understand issues and opportunities and partners with them to drive improvements.

Education & Experience Requirements

Essential: At least seven years of experience in both instrumentation and calibration in a GMP environment plus experience in managing GMP calibration programs with indirect people management.

Desired: Bachelor’s Degree in an engineering related field and/or significant military service experience in this field.

Other Requirements

Domestic and international travel required approximately 20%.

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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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Reasonable Accommodations

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.