Alkermes · 2 weeks ago
Director, Engineering and Reliability Services
Waltham, MA, United States
Full-time
Onsite
Director/Executive
$205K/yr - $226K/yr
15+ years expAlkermes is a fully-integrated, global biopharmaceutical company committed to developing medicines for complex psychiatric and neurological disorders. The Director, Engineering and Reliability Services will lead engineering activities, oversee cross-functional teams, and ensure effective engineering and procurement of necessary equipment and facilities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Plans, organizes, and leads site engineering function to effectively engineer and procure necessary equipment and facilities
Leads and personally participates in appropriate qualification/validation activities within the 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
Engages directly in commissioning activities and provides expert guidance to the commissioning team across the site
Contributes to site master plan and conceptual designs
Leads and participates in the development of Standard Operating Procedures for equipment and systems throughout the facility
Identifies and implements 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
Qualification
Required
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
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
Preferred
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
Benefits
Eligible for an annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-24
2026-01-20
Company data provided by crunchbase