Pharma GMP Project Leader

Validation & Engineering Group, Inc.; Gurabo (PR); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. is seeking a Project Manager to lead capital projects within regulated pharmaceutical and biotechnology environments. The ideal candidate will have a Bachelor's degree in Engineering and at least 8 years of experience managing project scope, schedule, budget, and compliance with GMP standards.

This role requires strong leadership and communication skills, with fluency in both English and Spanish. Responsibilities include overseeing project delivery and documentation while ensuring adherence to safety, quality, and schedule commitments.

Qualifications

• Minimum of 8 years of experience managing capital projects within regulated industries.
• Experience supporting projects through design, procurement, construction, and operational handover phases.
• Strong understanding of GMP environments and quality system expectations.
• Excellent verbal and written communication skills in both English and Spanish.

Responsabilités

• Lead overall project delivery, governance, and execution throughout the project lifecycle.
• Develop and maintain project plans, schedules, budgets, and resource strategies.
• Coordinate cross-functional teams to ensure compliance with GMP requirements.
• Handle project financial performance and reporting.
• Prepare and maintain project documentation including schedules and status reports.

Connaissances

Project management

Leadership

Technical coordination

Cross-functional collaboration

GMP environments knowledge

Risk management

Excellent communication skills

Analytical problem-solving

Formation

Bachelor’s degree in Engineering

Outils

MS Project

SAP

Planisware

Primavera

Description du poste

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
  
  

Position Summary

The Project Manager will lead and support a portfolio of capital projects and strategic initiatives within regulated pharmaceutical and biotechnology manufacturing environments. This role is responsible for managing projects through all phases of execution while ensuring alignment with business objectives, safety requirements, quality expectations, schedule commitments, and budget targets.

Projects may support manufacturing operations, packaging systems, process improvements, facility upgrades, cleanroom improvements, commissioning and qualification activities, operational excellence initiatives, utilities, and other regulated engineering programs.

The role requires strong leadership, technical coordination, and cross-functional collaboration with Engineering, Operations, Quality, Procurement, EHSS, Construction, external contractors, and equipment vendors.

Key Responsibilities

• Lead overall project delivery, governance, and execution throughout the project lifecycle.
• Develop and maintain project plans, schedules, budgets, forecasts, resource strategies, and risk management plans.
• Coordinate cross-functional teams to ensure projects are delivered safely, on schedule, within budget, and in compliance with applicable GMP and site requirements.
• Handle project financial performance including cost tracking, forecasting, variance analysis, and reporting.
• Support procurement coordination, contractor management, vendor management, and technical alignment activities.
• Lead project meetings and communicate project status, risks, issues, mitigation plans, and key decisions to stakeholders and leadership teams.
• Coordinate project scope changes, project documentation, and project-related change activities as required.
• Prepare and maintain project documentation including schedules, status reports, risk logs, budgets, meeting minutes, action trackers, and project closeout packages.
• Coordinate activities supporting commissioning, qualification, startup, operational readiness, and turnover to operations.
• Support project execution activities in alignment with applicable EHSS requirements and site procedures.
• Identify project risks, resource constraints, and execution challenges while driving timely resolution and escalation when needed.
• Support continuous improvement initiatives related to project execution, compliance, and operational performance.
  
  

Qualifications & Experience

• Bachelor’s degree in Engineering required.
• Minimum of 8 years of experience managing capital projects within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
• Demonstrated experience supporting manufacturing, packaging, facilities, utilities, process equipment, cleanroom environments, and regulated operational systems.
• Proven experience managing project scope, schedule, budget, risks, stakeholder communications, and cross-functional coordination.
• Experience supporting projects through design, procurement, construction, commissioning, startup, qualification, and operational handover phases.
• Experience coordinating with engineering firms, contractors, equipment vendors, and internal technical teams.
• Strong understanding of GMP environments, regulated project execution, and quality system expectations.
• Familiarity with project management, scheduling, cost tracking, and reporting tools such as MS Project, SAP, Planisware, Primavera, or similar systems is preferred.
• PMP certification is preferred.
• Excellent verbal and written communication skills in both English and Spanish, including technical writing, documentation preparation, meeting facilitation, and communication of project deliverables.
• Strong leadership, organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and complex project portfolios.
  
  

Additional Requirements

• Ability to work on-site in the eastern region of Puerto Rico.
• Must be eligible to complete client-required onboarding, training, and site access requirements.
• Ability to work effectively within fast-paced and highly regulated environments.
  
  

The above statements describe the general nature and level of work performed and do not represent an exhaustive list of responsibilities.

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.