Manager, Project Engineering

Role Summary

Manager, Project Engineering leads the design and construction of major capital projects, serves as the technical resource for EHS, Quality Assurance, Quality Engineering and R&D, and supports site strategy, continuous improvement, and manufacturing process enhancements within a pharmaceutical/ cGMP environment.

Responsibilities

• Work closely with the Finance Dept to develop and execute the site’s capital plan.
• Technical resource for EHS, Quality Assurance, Quality Engineering and R&D departments.
• Manage the design of major capital projects.
• Manage the construction of major capital projects.
• Maintain capital expenditure logs.
• Review drawings to ensure constructability and operation.
• Develop, estimate and track Capital Allocation Requests (CARs).
• Drive the development of new and/or modification(s) of manufacturing process and packaging equipment to support new and/or existing products and line extensions.
• Determine change parts requirements for new products to facilitate their manufacturing.
• Assist in startup of facility.
• As applicable, provide daily contact with vendors and contractors.
• Coordinate information between internal consults and users and with outside construction.
• Develop metrics to drive efficiencies within the Engineering department.
• Participate as a member of the Management Team in developing site strategies and policies and represent DPT at the manager level with customers and regulatory agencies.
• Support the site’s Continuous Improvement activities.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Perform other duties as assigned.

Qualifications

• Required: Bachelor’s degree (B.S.) in Engineering; minimum 8 years in pharmaceutical (cGMP) manufacturing (or similar) with supervisory experience, including at least 4 years at a manager level.
• Preferred: Certification in Lean and/or Six Sigma tool set.
• Familiarity with compounding equipment, aerosol manufacturing, piston-style bottle fillers, tube fillers, bottle capping and torquing equipment, and shrink bundling is a plus.
• Familiarity with OSHA PSM/PSA and cGMP is a plus.
• Strong interpersonal and team-building skills across multiple departments and levels.

Education

• Bachelor’s degree in Engineering is required.