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 engineersCapital 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 leadershipEngineering & 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 teamsSystems, 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 leadershipProduction & 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.