Director, Engineering and Reliability Services

Alkermes

12h • $205,000 - $226,000 • Onsite

About The Position

A leadership position in Site Operations group responsible for Reliability Services, supporting early research through clinical production. The Director, Engineering will actively engage in engineering activities, providing hands-on technical leadership while also effectively leading cross-functional, cross-organizational, multi-disciplinary teams to meet business objectives. This role is an onsite position based in our Waltham location and requires direct engagement with equipment, systems, and engineering processes. The Director is expected to work side-by-side with engineers and technicians as needed to diagnose issues, commission systems, validate equipment, and implement improvements.

Requirements

• 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.
• 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.
• Ability to work onsite in our Waltham facility

Nice To Haves

• 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.

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.

Benefits

• Alkermes offers a competitive benefits package.
• Additional details can be found on our careers website: www.alkermes.com/careers#working-here
• this position is eligible for an annual performance pay bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees