Shire Calibration Technician in Milford, Massachusetts
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 Ophthalmics. 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.
The Calibration Technician at the Shire bio-manufacturing facility in Milford, MA performs calibrations of manufacturing, quality control, building maintenance system, and safety instrumentation and maintains the calibration scheduling system to conform to facility requirements. The Calibration Technician coordinates the maintenance of QC laboratory instrumentation and equipment. The Calibration Technician supports the Maintenance organization in the execution of the PM program. The Engineering organization is part of an international network of manufacturing sites. All executed calibration work and system operation is in compliance with Shire Quality and Safety policies and principles.
Perform, document and complete calibrations for utility, building and process systems per established training on divisional calibration procedures using the RAM CMMS system.
Troubleshoot plant operational and instrumentation issues and provide corrective action.
Escort and manage service contractors for vendor calibrations and system repairs.
Plans and schedules service for QC laboratory equipment.
Executes maintenance as required to support the PM program.
Interface with transitioning shifts for updates.
Utilize spare parts inventory system to pick and document appropriate spare parts associated with instrumentation.
Communicate the status of calibrations performed and instrumentation issues to operational customer and maintenance management
Education and Experience Requirements
Working knowledge of metrology and calibration with an ability to deal with complex processes and procedures. Excellent communication skills and detail oriented.
Minimum education required is High School Diploma. Associates Degree preferred.
Candidate’s with experience in a in a CGMP environment is required. 3-6 years of experience working with calibration/metrology or process equipment in a regulated environment preferred.
Key Skills, Abilities, and Competencies
Instrumentation – Strong mechanical aptitude. Ability to choose and utilize appropriate tools. Ability to use electronic test and measurement equipment.
Computers – Knowledge of software including relevant applications such as Microsoft office. Experiences with Computerized Maintenance Management Systems (Blue Mountain RAM or equivalent) preferred.
Safety - Knowledge of relevant policies and procedures to ensure safe operation of mechanical systems and tools, particular knowledge of GMP policies and procedure preferred.
Complexity and Problem Solving
Trouble-Shooting and Repairing - Determine root causes of operating errors and instrumentation failures.
Oral and Written Comprehension - Ability to understand and read Standard Operating Procedures (SOPs).
Operation Monitoring – Watch and interpret gauges, dials, or other indicators to make sure equipment is working properly. Report and correct (or identify resources needed to correct) equipment deficiencies
Initiative – Position requires high degree of initiative in resolving problems and developing recommendations.
Reliability - Demonstrated reliability and an exemplary work record also required --including the willingness and ability to work extended hours, occasional holidays to support maintenance shut-downs, critical repairs and project implementation.
Internal and External Contacts
Coordination with vendors for the planning and scheduling of instrumentation and lab system calibration and preventive maintenance.
Internal planning and scheduling with QC and Manufacturing groups for service on instrumentation/equipment.
Other Job Requirements
Manufacturing environment with potential chemical, electrical and physical hazards.
Willingness to wear required PPE for which EHS training will be provided.
Must be able to walk at length around a multi-building facility and to stand for long periods of time while performing physical duties.
May be required to lift up to 40 lbs.
Must be able to work safely with materials, including chemicals, and mechanical equipment.
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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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.