Head of Engineering & Projects

Role Summary

Head of Engineering & Projects in Framingham, MA. This role oversees engineering and project delivery, ensures regulatory compliance, drives process improvements, and aligns departmental objectives with site and enterprise goals.

Responsibilities

• Provide input and studies to support decision making process with site leadership team and central function.
• Deciding on the initiation and funding of capital projects.
• Capital Project delivery model (workforce, study, execution plan, contracts with 3rd party...) for design to closure.
• Advising on strategies to ensure all engineering activities comply with industry regulations and standards.
• Implementing process improvements to enhance efficiency, safety, and quality within the engineering and maintenance groups.
• Selection and management of external contractors and suppliers to ensure they meet the company's standards and requirements.
• Staffing of site Engineering and Project teams based on site needs and strategic workforce planning.
• Performs strategic planning and development activities for site CQ, including compliance, capacity, timeline and direction.
• Align department objectives with Engineering and site business objectives.
• Collaborate with senior leadership in meeting organizational goals.
• Establish and report applicable department or organizational metrics.
• Direct the development of projects and conduct follow-up and reporting.
• Interact with project teams and cross functional groups.
• Represent department during internal and external audits and inspections
• Interface with external regulatory agencies as required.
• Ensure and maintain harmonized approaches across CQV teams

Qualifications

• Bachelor's degree in Engineering or Science and 12+ years of CQV or relevant experience, or
• Master‚Äôs degree in Engineering or Science and 10+ years of CQV or relevant experience
• 5 years of management/supervisory experience highly preferred

Specific Skills And Experience

• Project Management: Proficiency in planning, executing and monitoring large scale projects
• Technical Expertise: In-depth knowledge of engineering & maintenance principles on pharmaceutical manufacturing processes
• Regulatory Knowledge: Familiarity with pharmaceutical industry regulations, including GMP and FDA standards
• Problem-solving: Excellent analytical and problem-solving skills to address technical issues

Education

• Bachelor's degree in Engineering or Science with 12+ years CQV or relevant experience, or
• Master‚Äôs degree in Engineering or Science with 10+ years CQV or relevant experience

Additional Requirements

• 5 years of management/supervisory experience highly preferred