Project Manager | Pharmaceutical | Capex
Industry: Pharmaceutical Manufacturing
Position Type: Contract
Overview
The Project Manager will lead and coordinate Capital Projects, Automation, Utilities, Infrastructure, and Commissioning & Qualification (C&Q) projects within pharmaceutical manufacturing environments. This role ensures project planning, execution, timelines, resource allocation, and stakeholder communication while maintaining GMP compliance and industry standards. The Project Manager works cross-functionally with Engineering, Automation, Validation, Quality, Manufacturing, Facilities, Utilities, Construction teams, and external vendors to deliver projects successfully.
Responsibilities
- Lead and manage pharmaceutical capital, automation, utilities, infrastructure, and C&Q projects from planning through completion.
- Develop project schedules, timelines, budgets, and resource plans.
- Coordinate cross-functional teams including Engineering, Automation, Validation, Quality, Manufacturing, Facilities, Utilities, Construction, and external vendors.
- Monitor project progress and ensure milestones and deliverables are met.
- Identify project risks and develop mitigation strategies.
- Track project scope and manage changes effectively.
- Ensure compliance with GMP, FDA, and industry regulatory requirements.
- Support commissioning, qualification, validation, and startup activities for systems, equipment, facilities, and utilities.
- Manage projects involving automation systems, process control systems, utilities, facility infrastructure upgrades, and sterile manufacturing support systems.
- Facilitate project meetings and provide status updates to stakeholders and leadership.
- Maintain project documentation and ensure proper record management.
- Support continuous improvement initiatives and project execution strategies.
Qualifications
- Strong understanding of pharmaceutical manufacturing environments.
- Knowledge of Commissioning & Qualification (C&Q) lifecycle activities.
- Familiarity with GMP regulations and quality standards.
- Experience supporting capital projects, automation systems, utility systems, facility infrastructure projects, or construction activities within regulated environments.
- Knowledge of automation platforms, process control systems, Computer Systems Validation (CSV), or related technologies is preferred.
- Strong project planning and organizational skills.
- Excellent communication and stakeholder management abilities.
- Ability to prioritize multiple tasks and manage competing deadlines.
- Proficiency in Microsoft Office Suite and project management tools.
- Ability to work independently and in a team-oriented environment.
- Strong problem-solving and analytical skills.
Education
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Project Management, Construction Management, or related technical field.
- Project Management certifications (PMP or similar) are a plus.
Experience
- Minimum of 3 years of experience in Project Management within pharmaceutical, biotech, medical device, or regulated manufacturing environments.
- Experience supporting Capital Projects, Automation Projects, Utilities Systems, Infrastructure Projects, Construction Projects, or Commissioning & Qualification (C&Q) activities preferred.
- Experience managing cross-functional teams and project deliverables.
- Experience working with sterile manufacturing environments, process control systems, automation platforms, utilities, or facility infrastructure projects is highly desirable.
- Knowledge of pharmaceutical processes and regulatory environments preferred.
Physical Requirements
- Ability to work in office, manufacturing, laboratory, utility, and production environments.
- Ability to stand, walk, sit, and move throughout facilities for extended periods.
- May require occasional lifting of up to 20 lbs.
- Ability to wear required Personal Protective Equipment (PPE) in manufacturing areas.
- May require occasional travel to client sites or project locations.
- Ability to access controlled manufacturing, utility, construction, and cleanroom environments as needed.