Instrumentation Engineer

Job Description
Position Summary:
Alkermes is currently seeking askilled Instrumentation Engineer to join their Waltham facility. The individual will primarily be responsible for planning, installing, monitoring and maintaining the instrumentation and process equipment within a newly built Clinical Oral Solid Dose manufacturing suite. The ultimate aim of Instrumentation Engineer is to ensure that control machinery and process equipment are working to achieve maximum productivity in an optimally efficient, safe, compliant, and reliable manner.
Responsibilities

• Support all phases of the clinical manufacturing process.
• Serve as the primary contact / liaison with the clinical manufacturing team to develop engineering requirements, maintenance/contractor work, and resource availability. Screen and evaluate incoming and outgoing responses as appropriate.
• Ensure high Good Manufacturing Practices (GMP) and Environmental Health and Safety (EHS) standards are maintained, while adhering to schedules to meet the business requirements. Assist as needed in regulatory agency inspections.
• Locate and diagnose failures. Work through process to replace defective components including the completion of associated documentation, calibration and follow up tasks.
• Continually monitor and support equipment operations of the manufacturing suite and facility.
• Coordinate and supervise all OSD process equipment maintenance and calibrations.
• Ensure process equipment operations comply with quality parameters.
• Champion process improvement, commissioning, and qualification activities.
• Development of standard operating procedures and production staff training if required.
• 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 usually no more than once per month.
• Support the Site Operations team as needed.

Qualifications

• Experience and Knowledge in troubleshooting and use of control systems, including PLCs, BAS, DCS, SCADA and related software.
• Experience with information technology infrastructure components as they relate to industrial automation systems.
• Strong hands-on mechanical and electrical aptitude to understand and troubleshoot the equipment and machinery with which our systems interface. Previous field engineering experiences a plus.
• Experience in process, laboratory, and/or analytical instrument service with an understanding of diagnostics, calibration, and or repair.
• Engineering experience of standard DDC IO signaling and control, control wiring and process machinery
• General knowledge of pharmaceutical operations and equipment validations, in-depth knowledge of facility and utility validations.
• Experience with CGMP documentation lifecycle and process.
• Familiarity with industry standards and regulations such as ISA, ISPE, IEC, and NEC.
• Ability to create, read and interpret engineering drawings related to electrical instrumentation & controls using applicable software such as AutoCAD, Revit, Navisworks, Bluebeam, SKM or other relevant engineering software required.
• The ability to work independently as well as on a project team.

Education and Experience:

• BS in Engineering or a related field of study. Education may be substituted with industry experience of 5-10 years in Instrumentation & Controls.
• 5+ years of experience in a CGMP pharmaceutical manufacturing setting. Oral Solid Dose experience is a plus.
• Able to navigate interpersonal communication and compose clear and professional written business correspondence.
• Strong attention to detail and focus on quality, accuracy, and accountability.
• Possess personal qualities of integrity, credibility, and commitment to the organization's mission, vision, and values.
• This position requires full-time onsite presence at our Waltham, MA office.
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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.