Director, Engineering and Reliability Services at Alkermes, Inc. in Waltham, MA

GENERAL DESCRIPTION:

A leadership position in Site Operations group responsible for Reliability Services, supporting early research through clinical production. The Director, Engineering will effectively lead, direct, and integrate cross-functional, cross-organizational, multi-disciplinary teams to meet business objectives. This is an onsite position based in our Waltham location.

Responsibilities

KEY DUTIES:

Plans, organizes, and leads site engineering function to effectively engineer and procure necessary equipment and facilities.
Direct appropriate qualification/validation activities within department.
Oversight of team that supports companion Engineering dept functions in Reliability and Project Services.
Oversight of team that serves as equipment/technical owners of equipment and utilities throughout the site.
Oversight of team that performs the commissioning functions throughout the site.
Contributes to site master plan and conceptual designs.
Oversight of the development of Standard Operating Procedures for equipment and systems throughout the facility.
Identify and implement system improvements and operational excellence activities. within department, and support OE initiatives throughout the site.
Applies knowledge and innovation to proactively identify, communicate and implement required project/plan modifications and resolve problems.
Remain current on industry and FDA engineering standards and trends.
Plans and manages Reliability Services budget.
Serve as a member of the Engineering Forum to ensure alignment and best practices.
Oversight of Global Engineering Standards effort.

Qualifications

SKILLS/ABILITIES:

Thorough mechanical and chemical engineering knowledge as it applies to general facility systems and equipment, and drug product facility systems and equipment.
Thorough knowledge of electrical, electronic and instrumentation systems.
Thorough knowledge of computer systems operation and software.
In-depth knowledge of CGMP, OSHA, EPA and FDA facility requirements and regulations.
General knowledge of chemistry, statistics, facility design, cost estimation, process control and process scale-up.
General knowledge of pharmaceutical operations and equipment validations, in-depth knowledge of facility and utility validations.
Excellent communication and documentation skills.
"Hands-on" ability to troubleshoot and install mechanical, instrumentation and electrical equipment.
Ability to troubleshoot and maintain facility systems, equipment and processes.
Excellent people skills to supervise personnel and interact with other facility and research groups.
Excellent writing skills to prepare engineering and validation protocols, facility reports, summary documents, equipment specifications and SOPS, and batch records.
Ability to specify and size facility systems, equipment and process equipment.
In-depth knowledge of internal documentation control.

BASIC QUALIFICATIONS:

EDUCATION AND EXPERIENCE:

BS in Chemical, Electrical or Mechanical Engineering required.
15 years in Pharmaceutical facility operations, maintenance, ideally with Oral Solid Dose manufacturing and laboratory operation experience.
A keen ability to coach and mentor subject matter experts; to work collaboratively and effectively manage a team.
Experience in automation and instrumentation, validation, electrical power and electronics, clean utilities and facility design and construction required.

PREFERRED QUALIFICATIONS:

Must have experience with structured approaches to Risk Assessment (ex. FMEA) and an understanding of pharmaceutical Quality by Design (QbD).
Experience in Value Stream Leadership, with demonstrated leadership in the achievement of Operational Excellence.
Financial savvy in operational cost analysis and budget management.
Exposure to and understanding of U.S. and international regulatory standards and requirements.
Ability 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.