• Job Description

  Req#: 13558

  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.

  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

  #LI-TS1

  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.

• About the company

  Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology.

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