Project Engineering Manager | FDA Manufacturing Environment

The Project Engineering Manager reports to the Director of Engineering and is responsible for leading the execution of capital equipment, manufacturing infrastructure, warehouse, and plant-wide improvement projects. This role manages projects ranging from concept development through full production readiness, including equipment design, procurement, installation, validation, and commissioning.

Client Details

This organization is a leading science-driven health and wellness company, dedicated to delivering high-quality, research-backed products that empower individuals to take a proactive approach to long-term health.

Description

Project & Team Leadership

• Lead Project and Process Engineering teams in the selection, prioritization, and execution of high-impact projects aligned with business goals
• Build, hire, mentor, and retain a high-performing technical team while fostering a collaborative and safety-focused culture
• Serve as a technical delegate for the Engineering Director and mentor junior engineers

Capital Projects & Execution

• Develop comprehensive business cases and secure leadership approval for CapEx investments
• Create and manage detailed project schedules, budgets, and cost justifications
• Communicate project progress, risks, and mitigation strategies to leadership

Engineering & Technical Oversight

• Develop detailed equipment and system specifications in collaboration with Engineering, Safety, Maintenance, and external vendors
• Create and manage RFQs for complex projects; evaluate bids and negotiate optimal technical and commercial solutions
• Lead equipment installations, including utilities, start‑up testing, commissioning, and handoff to operations
• Partner with Controls teams to define process monitoring and automation strategies
• Support validation activities (IQ, OQ, PQ) in collaboration with Quality and Validation teams

Systems, Compliance & Optimization

• Develop, review, and maintain engineering standards and foundational systems including drawings, PFMEAs, project management, and risk management methodologies
• Lead and support Factory Acceptance Tests and Site Acceptance Tests (SAT), including offsite travel as required
• Stay current on emerging manufacturing technologies and provide actionable recommendations to leadership

Production & Operations Support

• Support company-wide continuous improvement initiatives
• Act as a Subject Matter Expert (SME) for troubleshooting complex equipment and process issues
• Review SOPs, change controls, and other technical documentation as needed
• Identify equipment capability gaps and recommend solutions to meet production targets
• Provide technical guidance during process deviations, equipment failures, and audit responses

Profile

• Bachelor's degree in Mechanical Engineering (or equivalent combination of education and experience)
• 7-10 years of hands-on experience in Project Engineering or Manufacturing Engineering within an FDA-regulated environment
• Strong leadership experience mentoring junior engineers and interns
• Experience with plant expansion, automation, or high-speed packaging lines
• Advanced proficiency in SolidWorks for mechanical design and technical problem-solving
• Ability to develop production layouts in AutoCAD and build cross-functional consensus
• Strong proficiency in MS Project, including resource planning and timeline management
• Expert-level experience facilitating PFMEAs and risk assessments

Job Offer

• Salary: $150,000 - $170,000
• 100% company-paid medical, dental, and vision insurance coverage for employees
• Company-paid short- and long-term disability insurance
• Company- paid life insurance
• 401k plan with employer matching contributions up to 4%
• Gym membership reimbursement

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.