Project Manager

• Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
• People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
• Project / Program Management: Lead initiation, planning, execution, control, and close-out activities; ensure team ownership of plans, schedules, and budgets.
• Process Management: Ensure activities follow established processes; maintain documentation discipline.
• Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
• Responsible for programming, planning, developing and updating schedule for assigned projects.
• Manage the project(s) to assure full compliance with planning for the entire project duration.
• Attend to all meetings with client's representatives and contractors.
• Conduct meetings with staff, contractors and client.
• Review documentation related and onsite conditions.
• Develop Scope of Work and Bid packages for contractor solicitations.
• Review and recommend best contractor's proposals for construction's packages.
• Assist client with Design Development, Construction Document Review, and Construction Administration Phases.
• Evaluate equipment submittals and prepare client's recommendation.
• Prepare and deliver monthly and weekly reports.

• 5–7+ years of experience in large scale project development within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
• A Bachelor's Degree in Engineering is required. Professional Engineer Licence or PMP Certification is a plus.
• Strong knowledge of FDA Regulation and Good Manufacturing Practices (cGMP).
• Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
• Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
• Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
• Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
• Excellent computer skills, including MS Project, Microsoft Office suite and Google platforms.
• Applicant must also have excellent interpersonal skills and be self-motivated.
• Demonstrated experience in personnel management and customer service skills
• Possess excellent communication and oral skills.
• Demonstrated ability to effectively prioritize and execute tasks in a high-pressure environment.
• Strong attention to detail.
• Experience with budget and estimates of capital projects.
• Capable of writing clear and comprehensive reports.

• Engineering bachelor's degree.

• Bachelor's (Required)

• Regulated industry Capital Projects: 5 years (Required)

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