Regulated Pharma/Med Devices Project Manager

Validation & Engineering Group, Inc.; Humacao (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Project Manager to lead capital and engineering projects in a regulated environment. This role involves planning and coordinating across various technical teams to ensure quality and compliance.

The ideal candidate should have a Bachelor’s degree in Engineering and extensive project management experience. You will support various initiatives, driving accountability and fostering a culture of safety and quality.

Qualifications

• 5–10 years of experience in project management within regulated environments.
• Experience managing engineering, capital, and operational excellence projects.

Responsibilities

• Lead and coordinate multiple projects ensuring adherence to project objectives.
• Facilitate project meetings and communicate status to stakeholders.
• Monitor project performance and document compliance.

Skills

Project management

Engineering

Cross-functional leadership

Risk management

Effective communication

Stakeholder management

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Project

Smartsheet

Primavera P6

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Project Manager
  
  

Description

We are seeking a Project Manager to lead and coordinate capital, engineering, manufacturing, quality, validation, automation, and operational improvement projects within a regulated pharmaceutical, biotechnology, or medical device environment.

The Project Manager will be responsible for planning, executing, monitoring, and closing projects while ensuring alignment with scope, schedule, budget, quality, and compliance requirements. This individual will serve as the primary point of coordination among cross-functional stakeholders and will drive project execution from initiation through completion.

Key Responsibilities

• Manage multiple projects simultaneously, ensuring adherence to project scope, schedule, budget, and quality objectives.
• Develop and maintain project plans, schedules, resource forecasts, risk registers, and status reports.
• Coordinate activities among Engineering, Manufacturing, Quality, Validation, Automation, Supply Chain, and other functional teams.
• Facilitate project meetings and communicate project status, risks, issues, and mitigation plans to stakeholders and leadership.
• Monitor project performance using established KPIs and project management best practices.
• Support capital project execution, equipment implementation, facility upgrades, process improvements, technology transfers, and operational initiatives.
• Identify and proactively manage project risks, issues, and dependencies.
• Ensure project documentation is complete, accurate, and compliant with applicable procedures and regulatory requirements.
• Drive accountability among team members and support timely decision-making.
• Support vendor management, contractor coordination, and procurement activities as required.
• Promote a culture of safety, quality, compliance, and continuous improvement.
  
  

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical, Industrial, Civil, Biomedical, or related engineering discipline).
• 5–10 years of project management experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience managing engineering, capital, manufacturing, quality, validation, automation, or operational excellence projects.
• Demonstrated experience leading cross-functional teams and coordinating multiple stakeholders.
• Strong understanding of project planning, scheduling, budgeting, forecasting, and risk management.
• Excellent verbal and written communication skills, with the ability to effectively interact with technical teams, management, and clients.
• Proficiency with Microsoft Project, Smartsheet, Primavera P6, or equivalent project management tools.
  
  

Preferred

• PMP certification.
• Experience supporting GMP-regulated environments.
• Experience managing capital projects, facility expansions, equipment installations, CQV programs, process improvements, or technology transfers.
• Familiarity with FDA regulations, cGMP requirements, and life sciences industry standards.
  
  

Soft Skills

• Strong leadership and organizational skills.
• Excellent interpersonal and stakeholder management abilities.
• High emotional intelligence and professional maturity.
• Strong problem-solving and decision-making capabilities.
• Ability to influence and drive results without direct authority.
• Self-motivated, proactive, and highly accountable.
• Ability to work effectively in a fast-paced, matrixed environment.
  
  

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.