Process Automation Engineer at Alkermes, Inc. in Waltham, MA

GENERAL DESCRIPTION:

Alkermes is currently seeking askilled Process Automation Engineer to join their Waltham facility. The individual will be responsible for the design, programming, monitoring and maintenance of production and facilities process automation systems. Job duties include configuration and support of PLC code, resolution of automation equipment issues and adherence to standard operating procedures (SOP’s) in a GxP regulatory environment. The ultimate aim of Process Automation 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. This is located onsite in our Waltham facility.

Responsibilities

KEY DUTIES:

Assist in the planning, development, and deployment of automation solutions for on-site equipment
Provide run-the-business automation equipment of manufacturing systems including after-hours on-call
Write and edit design documentation, both functional and detailed specifications
Assist with the start-up, commissioning, and validation of automation systems
Monitor existing system performance and implement industry best-practice improvements
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.
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

BASIC QUALIFICATIONS

EDUCATION AND EXPERIENCE:

Bachelor’s degree or higher preferred (Engineering or Computer Science)
Automation manufacturing systems experience (3-5 years) Oral Solid Dose experience is a plus.
Experience with Rockwell FactoryTalk or comparable software systems required
PLC and HMI programming experience required
Experience with Siemens PLC automation systems a plus
Experience with ANSI/ISA-88 batch process control standards a plus
Experience and support for 21CFR part 11 and Good Manufacturing Practices desired
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.

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%).
Must be able to work onsite 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.