Maintenance Technician-Solid Dose 9/11/2016
JOB DESCRIPTIONAPPLY Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland and Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
An intermediate level technician position involving general maintenance and preventive maintenance activities, with Oral Solid Dose production equipment, under limited direct supervision intended to keep the equipment within operational specifications and safe. This position is part of a 24 hour/7 day operation and may require assignment to a regular off shift and weekends schedule.
* Perform PMs
* Follow Written Preventative Maintenance Procedures.
* Accurately complete maintenance paperwork, including work orders and logbooks.
* Review and update maintenance procedures based on field experience.
* Review and redline drawings to reflect as built conditions.
* Identify opportunities for improving PM program.
* Accept ownership of selected equipment and serve as point person for repairs/PM.
* Train fellow mechanics on technical details.
* Identify critical spare parts based on field experience,
* Execute Repairs
* Respond to customer requests and/or alarm conditions.
* Assess breakdowns, systematically identify problems, and restore to operation.
* Accurately document repair activities.
* Support Quality Assurance investigations of breakdowns.
* Contractor Support
* Supervise contractors performing tasks within building.
* Ensure that contractor employees follow Alkermes safety and cGMP standards.
* Oversee technical quality of work performed.
* Lead Small Projects
* Identify facility/utility improvement projects, develop scope and estimates, and manage small ( $10K) projects to completion.
* Contribute to facility support activities such as office moves, area reconfiguration, painting, etc.
* Technical knowledge
* Experience with OSD equipment, such as Tablet Press, Coating, Blender, Mill, is preferred
* Good mechanical aptitude.
* Good pipe fitting, plumbing, and industrial maintenance skills.
* Good knowledge of rotating machinery (pumps, fans, blowers).
* Good knowledge of electrical systems and electronics.
* General understanding of automation systems.
* Basic understanding of engineering principles as they apply to facility and production equipment.
* Ability to read P&IDs and other engineering documents.
* Hands-on ability to isolate problems and identify root cause of issues.
* Ability to assist others with troubleshooting direction.
* Ability to manage multiple problems with supervisory direction.
* Able to lift/move 40 lbs overhead.
* Facility Maintenance and Operation
* Experience with general facility systems and equipment
* Ability to clearly describe technical issues.
* Writing Skills
* Ability to clearly and neatly document work performed.
* Ability to revise maintenance procedures that clearly define required tasks.
* Ability to proofread others work for accuracy.
* Good knowledge of OSHA safe work practices.
* Good understanding of cGMP, GDP, and FDA requirements as they apply to maintenance.
* Pharmaceutical Operations
* Knowledge of basic pharmaceutical manufacturing technology including washers, HEPA filters, etc.
* Knowledge of Clean Utility technology
* Sanitary piping principles including pipe specification, valve configuration, pump setup, etc.
* Ability to gown in an aseptic manner.
* Computer Systems
* Good knowledge of Process Control and Instrumentation Systems.
* Basic knowledge of typical office automation software suite.
* 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.
* 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 OT requirements.
EDUCATION AND EXPERIENCE:
* High School Diploma or equivalent.
* Two year technical degree or trade school a plus.
* Five to Ten years of maintenance experience.
* Three to seven years experience in pharmaceutical industry.
* Must be able to pass a DEA background check.
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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.