Location : Gurabo, PR – On Site
We are seeking a motivated and detail-oriented Project Manager with experience supporting pharmaceutical projects and Commissioning & Qualification (C&Q) activities. The ideal candidate will possess strong leadership, communication, and organizational skills and be capable of managing multiple projects while ensuring compliance with regulatory and quality standards. This individual will play a key role in driving project execution from initiation through completion.
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Lead and manage pharmaceutical C&Q projects from planning through completion.
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Develop project schedules, timelines, budgets, and resource plans.
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Coordinate cross-functional teams including Engineering, Validation, Quality, Manufacturing, and external vendors.
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Monitor project progress and ensure milestones and deliverables are met.
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Identify project risks and develop mitigation strategies.
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Track project scope and manage changes effectively.
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Ensure compliance with GMP, FDA, and industry regulatory requirements.
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Support commissioning, qualification, and validation activities for systems, equipment, and facilities.
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Facilitate project meetings and provide status updates to stakeholders and leadership.
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Maintain project documentation and ensure proper record management.
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Support continuous improvement initiatives and project execution strategies.
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Strong understanding of pharmaceutical manufacturing environments.
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Knowledge of Commissioning & Qualification (C&Q) lifecycle activities.
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Familiarity with GMP regulations and quality standards.
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Strong project planning and organizational skills.
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Excellent communication and stakeholder management abilities.
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Ability to prioritize multiple tasks and manage competing deadlines.
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Proficiency in Microsoft Office Suite and project management tools.
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Ability to work independently and in a team-oriented environment.
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Strong problem-solving and analytical skills.
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Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Project Management, or related technical field.
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Project Management certifications (PMP or similar) are a plus.
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Minimum of 3 years of experience in Project Management within pharmaceutical, biotech, or regulated manufacturing environments.
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Experience supporting Commissioning & Qualification (C&Q), validation, engineering, or capital projects preferred.
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Experience managing cross-functional teams and project deliverables.
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Knowledge of pharmaceutical processes and regulatory environments preferred.
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Ability to work in office, manufacturing, laboratory, and production environments.
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Ability to stand, walk, sit, and move throughout facilities for extended periods.
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May require occasional lifting of up to 20 lbs.
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Ability to wear required Personal Protective Equipment (PPE) in manufacturing areas.
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May require occasional travel to client sites or project locations.
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Ability to access controlled manufacturing and cleanroom environments as needed.
