Lead Maintenance Technician- OSD at Alkermes, Inc. in Waltham, MA

GENERAL DESCRIPTION:

An advanced level technician position primarily responsible for general maintenance and preventive maintenance activities of our Oral Solid Dose clinical manufacturing equipment. The role will operate under limited direct supervision and charged with keeping the equipment within operational specifications and safe.

Essential duties include the corrective and preventive maintenance of the OSD equipment, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols. The role will assist with troubleshooting, Identification, and implementation of process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation to identify risks and weaknesses in new and current processes. This is an onsite role in our Waltham facility.

Responsibilities

KEY DUTIES:

Perform PM’s
Follow Written Preventative Maintenance Procedures
Accurately complete maintenance paperwork, including work orders and logbooks.
Supervise and review the work performed by others.
Review and update maintenance procedures based on field experience.
Review and update drawings to reflect as built conditions.
Identify opportunities for improving PM program.
Recommend changes to PM program based on experience with equipment and analysis of historical data.
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 (<$15K) projects to completion.
Train on-site mechanics on technical details and procedures.
On-Call and Emergency Response. Respond to a variety of problems that may and do occur. Locate, determine, and correct problems or contact appropriate personnel for assistance. On-Call duties responding to emergencies 24 Hours/Day. On-Call rotation is usually one week out of every six.

Qualifications

Knowledge/Skills Needed:

Superior mechanical aptitude
Good pipe fitting, plumbing, and industrial maintenance skills
Good knowledge of rotating machinery (pumps, fans, blowers)
Thorough mechanical / electrical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
Knowledge of automated control systems.
Knowledge of computer systems operation and software.
Thorough knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
Knowledge of chemistry, statistics, equipment design, process control, and process scale-up.
"Hands-on" ability to install and troubleshoot instrumentation and equipment.
Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
Ability to author high-quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications, SOPs, deviation investigations).
Ability to specify and size manufacturing systems, equipment, and process equipment.
Ability to read, understand, and accurately follow company SOPs and guidelines.
Familiarity with OSD companies such Korsch, Glatt, Freund Vector, Syntegon, Netzsch and Gerteis.

BASIC QUALIFICATIONS:

EDUCATION AND EXPERIENCE::

5+ years of Oral Solid Dose equipment experience, such as Tablet Press, Coating, Blender, Mill (Mandatory).
10+ years of pharmaceutical experience
Seven to Fifteen years of maintenance experience.
Two year technical degree or trade school (BS degree preferred).

PREFERRED QUALIFICATIONS:

Physical Requirements:

Ability to lift/move 40 lbs. overhead.
Must be able to be medically cleared for respirator use (PAPR)
Ability to operate different types of production equipment.
Ability to gown correctly for clean room manufacturing operations.
Ability to stand or sit for extended periods (up to 4 hours at a time).
Must be able to work in an office and a manufacturing environment.
Some travel required (< 10%).
Ability to work in our Waltham facility

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.