Note: The job is a remote job and is open to candidates in USA. Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is a leading services supplier in the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Project Manager to lead and support capital projects and strategic initiatives within regulated environments, ensuring alignment with business objectives and safety requirements.
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
Skills
- 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
- 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
- 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
- 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
Company Overview