Sr. Calibration Technician - Full-time / Part-time

BUSINESS TITLE: LEAD CALIBRATION TECHNICIAN

SUMMARY:

The Calibration Lead at the biomanufacturing facility in Milford executes and manages the Calibration program at a high level of safety, compliance and reliability to support CGMP biologic drug manufacturing activities. The position is responsible for performing and documenting calibrations and troubleshooting instrumentation issues. The Calibration Lead supports the specification of new instrumentation to support the manufacturing site. The Calibration Lead provides leadership and guidance to the Maintenance and Operations teams and is a part of ongoing site and global calibration initiatives. The Maintenance organization is part of an international network of manufacturing sites. All executed calibration work and system operation is in compliance with Quality and Safety policies and principles.

* Manage the RAM CMMS system for the calibration of instrumentation, assessment Out of
Tolerance events and for lifecycle management of instrumentation assets.
* Perform, document and complete calibrations for utility, building and process systems per
established training on divisional calibration procedures using the RAM CMMS system.
* Maintain the compliant calibration of site standards and the operational state of Calibration lab
and history files.
* Develop calibration methodology and procedures for newly installed instrumentation and
equipment.
* Collaborate with Reliability Engineering and Planning Scheduling to update critical spares and
calibrations in aim of high quality Calibration work.
* Specify and purchase new instrumentation to support the manufacturing site.
* Generate technical reports, trends, calibration documents and analysis to support site
Operations.
* Own and support CAPA events and Change Controls in support of Calibration operations.
* Troubleshoot plant operational and instrumentation issues and provide corrective action.
* Support the life cycle management of BMS points, project work, reliability initiatives and site
CAPEX plan.
* Escort and manage service contractors for vendor calibrations and system repairs.
* 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.

* In depth experience and knowledge of metrology and calibration with an ability to deal with
complex processes and procedures. Must be able to demonstrate judgment and initiative in
problem resolution. Must be able to work unsupervised. Excellent communication skills and
detail oriented.
* Minimum education required is High School Diploma. Associates Degree preferred.
* 7-9+ years of experience working with calibration or metrology in a regulated environment.
Candidates with experience in a in a CGMP environment is required.

PROFESSIONAL CERTIFICATIONS:

* ISA Certified Control Systems Technician and/or ASQ Certified Calibration Technician preferred

Technical Knowledge Required

* Instrumentation - Detailed knowledge of instrumentation classifications to support
biopharmaceutical operations, calibration methods, standard applications, reverse traceability,
tolerance and frequency, OOT investigations, calibration databases, scheduling and ability to
specify instrumentation to support process applications.
* Process Controls - Working knowledge of control and monitoring systems.
* 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.

ADDITIONAL SKILLS & ABILITIES:

* Trouble-Shooting and Repairing - Determine root causes of operating errors and
instrumentation failures.
* Oral and Written Comprehension - Ability to understand and read and 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.

Must be able to be on call as required and carry a cell phone to respond to facility emergencies.

About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy.