• Supervise, train and provide technical guidance to Metrology staff.
• Review calibration schedules and insure proper staffing is available to meet timeline requirements.
• Perform hands on calibrations as necessary to augment Metrology staff.
• Review training requirements for calibration technicians and prepare training plans to insure continued compliance to cGMP requirements.
• Prepare Metrology data for internal and external auditing bodies.
60%: Supervise ongoing metrology lab operations to comply with corporate quality standards and timeliness of calibration/instrumentation repair work flow. Review and approve calibration events/records to meet all regulatory and user requirements. Ensure calibration activities for all new and existing equipment are performed in accordance with a set schedule and standard operating procedures.
15%: Perform calibration on Shire Metrology Standards, or review external calibrations performed on Shire Metrology Standards to insure continued NIST/intrinsic traceability.
15%: Review and approve calibration requirements of new instruments. Perform review of external calibrations verifying compliance with all internal and external quality standards.
5%: Prepare and review technical reports for tracking and trending. Perform measurements using Shire Metrology Standards and present data for measurement uncertainty analysis.
Education & Experience Requirements:
• Bachelor of Science or equivalent
• 7+ years of experience in a metrology environment
• 2+ years of supervisory experience
Other Job Requirements:
• The ability to work at all Shire HGT site locations/facilities.
• Perform "on-call" coverage to support operations as required.
• Ability to lift 50 lbs.
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.