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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading cross-functional manufacturing projects, ensuring compliance with cGMP and ISO 13485 standards while managing project financials and risks. Proficient in project scheduling, validation strategies, and collaboration with quality and regulatory teams.
Highest-signal resume keywords
Project ManagementRegulated Medical Device ExperienceRisk ManagementChange ControlPMP Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project SchedulingProcess ValidationEquipment QualificationDesign TransferBudget ManagementResource PlanningCritical Path MonitoringManufacturing ReadinessQuality Systems KnowledgeLean Six Sigma
Soft Skills
Strong CommunicationProblem-SolvingFacilitationOrganizational Skills
Tools & Technologies
ERP SystemsPLM SystemsQMSProject Portfolio Management SystemsSpreadsheet ToolsPresentation ToolsCollaboration Tools
Certifications & Qualifications
PMP Certification
Industry Keywords
CGMPISO 13485FDA RequirementsValidation RequirementsControlled DocumentationManufacturing EnvironmentBiotechnologyPharmaceuticalsCapital ProjectsThird-Party Supplier Management
Tech Stack
Tools & technologiesERPPMP
About the role
Key responsibilities & impact- Lead cross-functional manufacturing projects from charter and planning through execution, implementation, and closeout
- Develop project scope, schedules, resource plans, budgets, milestones, and deliverables
- Drive projects involving new product introduction, design and technology transfer, process validation, equipment qualification, automation, facility improvements, and capacity expansion
- Monitor project schedules and critical paths, proactively addressing issues affecting safety, quality, delivery, cost, or compliance
- Identify and manage project risks, issues, assumptions, and dependencies; escalate critical decisions when needed
- Coordinate manufacturing readiness, including validation strategies, training, documentation, material availability, and production ramp-up
- Partner with Quality and Regulatory teams to ensure compliance with cGMP, ISO 13485, applicable FDA requirements, change-control processes, validation requirements, and internal procedures
- Lead project governance and phase-review meetings, establish accountability, and drive timely decision-making
- Manage project financials, including capital requests, forecasts, purchase commitments, cost tracking, and variances
- Partner with suppliers, contractors, and equipment vendors to ensure deliverables meet quality, schedule, and commercial expectations
- Provide updates to project sponsors and senior leaders regarding progress, risks, decisions, and resource needs
- Capture lessons learned and strengthen project-management practices across the manufacturing organization
Requirements
What you’ll need- Bachelor’s degree in Engineering, Operations, Life Sciences, Business, or a related field
- 5+ years of experience in project management, engineering, operations, or manufacturing
- At least 3 years of experience within a regulated medical device, pharmaceutical, biotechnology, or similarly controlled manufacturing environment
- Demonstrated success leading cross-functional projects with accountability for schedule, budget, risk management, and leadership communication
- Working knowledge of quality systems, change control, validation, risk management, and controlled documentation
- Strong communication, facilitation, problem-solving, and organizational skills
- Proficiency with project scheduling, presentation, spreadsheet, and collaboration tools
- PMP or equivalent project-management certification preferred
- Experience with design transfer, process validation, equipment qualification, or manufacturing-site expansion preferred
- Lean, Six Sigma, or structured problem-solving experience preferred
- Experience with ERP, PLM, QMS, or project portfolio management systems preferred
- Experience leading capital projects and managing third-party suppliers or contractors preferred
Benefits
Comp & perks- Comprehensive pay and benefits package
- Equal opportunity employer
- Reasonable accommodation available for applicants with disabilities