What are the responsibilities and job description for the VP, Engineering position at BERKSHIRE STERILE MANUFACTURING LLC?
Position Summary
The Vice President of Engineering will oversee all engineering activities, ensuring that site operations meet regulatory standards and deliver high-quality sterile products. This role involves leading the engineering and maintenance team, managing projects, ensuring equipment reliability, and driving continuous improvement in a highly regulated environment.
Duties and Responsibilities
Oversee capital projects from conception through to completion, ensuring delivery on-time, within budget, and to specifications.
Ensure the reliability of all plant equipment, including critical utilities and process equipment, through effective maintenance programs.
Oversee the installation, commissioning and qualification of new equipment.
Develop and maintain preventative and predictive maintenance programs.
Develop and maintain a site master plan inclusive of property, plant, equipment and critical utilities.
Drive continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality.
Manage site services including cleaning, landscaping and routine maintenance.
Develop and manage the engineering budget ensuring cost effective use of resources.
Regulatory Responsibilities
Ensure all engineering activities comply with FDA, EMA, and other regulatory requirements.
Participate in regulatory audits and address any findings promptly.
Supervisory Responsibilities
Lead and mentor the team, fostering a culture of responsiveness and operational excellence.
Develop and implement department strategies aligned with the site’s goals.
Collaborate with other department heads to ensure seamless operations.
Experience
Candidates must have at least 5 years of GMP engineering experience.
Experience with automated production equipment and building control systems.
At least 5 years of utilities and process equipment engineering experience.
At least 10 years of experience leading site Engineering teams.
Sterile pharmaceutical experience preferred.
Education
BS Engineering
MBA or equivalent leadership training preferred
Knowledge, Skills & Abilities
Excellent verbal and written communication skills.
Ability to influence and collaborate cross-functionally.
Effective mentoring and leadership.
Physical Requirements
Ability to sit and stand for prolonged periods of time as required
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