Company Overview:

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

GENERAL DESCRIPTION:

A technical position involving instrument calibrations and operation intended to keep the facility instrumentation and equipment (i.e. process, utility, and general equipment) within compliance of cGMPs. This position supports a 24 hour/7-day operation and normally is day shift with occasional overtime required, as needed to meet customer needs.

KEY DUTIES:

• Perform Calibrations
• Follow written calibration procedures.
• Accurately complete calibration paperwork, including work orders and logbooks.
• Able to perform calibration of all types of plant instruments located throughout the plant.
• Maintain calibration documentation that demonstrates each instrument's NIST Traceability.
• Maintain and troubleshoot facility standalone instrumentation and control systems.
• Review and update calibration procedures based on field experience.
• Identify opportunities for improving Calibration program.
• Provide leadership and technical direction to fellow Metrologist on technical details.
• Arrange monthly calibrations performed by contractors.
• Review and update drawings to reflect as built PLC drawings.
• Able to install instrumentation.
• Able to specify instrumentation.
• Able to prioritize workload.
• Execute Repairs
• Respond to customer requests and/or alarm conditions.
• Assess instrument failures/breakdowns, systematically identify problems, and restore to operation.
• Accurately document repair activities.
• Support Quality Assurance investigations of instrument failures/ breakdowns.
• Operate Site Utility Systems
• Able to understand and operate equipment in order to perform system calibrations or perform complex troubleshooting activities.
• Able to operate equipment unsupervised.
• Contractor Support - Internal
• Support contractors performing tasks within building.
• Ensure that contractor employees follow Alkermes safety and cGMP standards.
• Oversee technical quality of work performed.
• Contractor Support - External
• Coordinate POs, shipping, receiving and tracking of devices sent for external calibration.
• Ensure that work follows Alkermes cGMP standards.
• Oversee technical quality of work performed and accuracy of documentation.

SKILLS/ABILITIES:

• Technical knowledge
• Thorough knowledge of principles and theory of pressure, temperature and weight sensing devices.
• Good mechanical aptitude.
• Thorough knowledge of electrical systems and electronics.
• Thorough knowledge of instrumentation principles and practices.
• Good understanding of pneumatic, electrical, and mechanical control systems.
• Good knowledge of automation systems.
• Good understanding of engineering principles as they apply to facility and production equipment.
• Thorough knowledge of electrical schematics, wiring diagrams, and P&IDs.
• Good knowledge of PID controllers.
• Thorough knowledge of instrumentation field wiring and to PLCs (Loop Powered and self-powered instruments, RTDs, thermocouples, etc.)
• Detail oriented.
• Troubleshooting
• Hands-on ability to isolate problems and identify root cause of issues.
• Ability to focus on problem at hand in systematic manner.
• Able to lift/move 40 lbs. overhead.
• Able to troubleshoot complex systems and instruments.
• Communication
• Ability to clearly describe technical issues.
• Writing Skills
• Excellent technical writing skills (investigation reports).
• Ability to clearly and neatly document work performed.
• Ability to revise calibration procedures that clearly define required tasks.
• Ability to proofread other's work for accuracy.
• Ability to clearly and effectively completed deviations.
• Regulatory
• Working knowledge of OSHA safe work practices.
• Excellent understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus.
• Good knowledge of NIST applied to calibrations
• Pharmaceutical Operations a plus
• Ability to gown in an aseptic manner.
• Computer Systems
• Good knowledge of Process Control and Instrumentation Systems.
• Good knowledge of typical office automation software suite.
• Good understanding of pneumatic, electrical, and mechanical control systems.
• Good knowledge of CMMS system.

PERSONAL ATTRIBUTES:

• Teamwork
• Works effectively as a team member in collaborative manner.
• Comfortable working in production environment with multiple priorities.
• Able to juggle multiple tasks with supervisory guidance.
• Positive Attitude
• Role Models "can-do" attitude.
• Reinforces positive approach in daily group activities.
• Readily adapts to changing job duties.
• Troubleshooting
• Good ability to acquire data, organize, analyze, and reach accurate conclusions.
• Detail Oriented.
• Sense of Urgency
• Comfortable working in culture that emphasizes responsiveness.
• Works to ensure that customer timelines are understood and met.
• Able to provide off-shift coverage.
• Able to support call-in and overtime requirements.

Basic Requirements:

• High School Diploma or equivalent.
• Five to ten years of calibration or maintenance experience.
• Must be able to pass a DEA background check.

Preferred Requirements:

• Two year technical degree or trade school a plus.
• Three to seven years experience in a regulated industry a plus.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.