Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic. 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.
Perform maintenance, installation, troubleshooting, calibration and repair of a variety of circuits, components, analytical equipment, controls and instruments for laboratory and manufacturing equipment.
Shire, a leading provider of therapeutic treatments that save, sustain and improve the lives of people with rare conditions, chronic diseases or limited treatment options. Supported by advanced technical and manufacturing expertise, its broad pipeline is built on a legacy of innovation in bleeding disorders and immunology, and is expanding to address unmet medical needs in niche areas of oncology, as well as technology platforms such as gene therapy.
- Follow sequence of testing from calibration procedures for instruments and equipment and ensure all tasks are performed in compliance with applicable Standard Operating Procedures.
- Prepare technical reports, perform trending on equipment and processes, and determine acceptability of product and processes based on data analysis and specification.
- Assist with outside audits for vendors in contract calibration laboratories.
- Create and maintain equipment file for each piece test/manufacturing equipment requiring calibration.
- Set up standards and special purpose laboratory equipment to test, evaluate, and calibrate other instruments and test equipment.
- Assist engineers in evaluation plans and procedures, to maintain precision accuracy of measuring, recording and indicating instruments and equipment.
- Investigate failures and instruments that are out of tolerance, and determine acceptability of product and processes. Assist in the preparation of documentation of investigation findings.
- Assists with development and implementation of technically defensible calibration procedures and new instruments being considered at the Facility.
- Build and maintain relationships with customers with the concept that metrology is a service provider to the customer.
- Coordinates the assigned activities and schedules of calibrations throughout the facility, including routine and non-routine work.
- Works with minimum supervision and makes scientific judgments related to instrumentation problem solving.
- Must have knowledge of Metrology concepts, including accuracy, precision and uncertainty. Must be able to deal with moderately complex processes.
- Demonstrates interpersonal skills with the ability to interface and influence personnel of all levels and participate effectively and efficiently in a team environment.
- Reads and understands P&IDs and advanced understanding of instrumentation, process and controls.
- Must have basic knowledge of PLC and digital based control systems and their instrumentation interfaces.
- Must be able to work unsupervised and demonstrate judgments and initiative in problem resolution.
- Must have solid mathematical skills.
- Must be able to plan and complete assigned activities on time.
- Strong professional writing skills.
- Strong assessment and troubleshooting skills.
- High School diploma or equivalent required.
- 0-6 years of experience in calibration in combination with education.
- Associate degree or other technical training preferred but not required.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.