What are the responsibilities and job description for the Project Engineering Manager | FDA Manufacturing Environment position at Michael Page?
- Experience in an FDA Regulated Environment is Required
- Knowledge of Creating Production Line in AutoCAD
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.
Job 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
- 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
- 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
- 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
- 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
The Successful Applicant
- 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
- 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
Quote job ref: JN-042026-6988183
Salary : $150,000 - $170,000