Project Manager, Operations Management, Regulatory Compliance Specialist

For over 25 years, the Life Sciences division of Trinity Consultants has supported clients in the pharmaceutical, biotechnology, and medical device industry. Trinity’s Life Sciences consulting team is a well-known leader in the industry

Our Life Sciences consulting team focuses on providing highly technical expertise in Engineering, Validation, Automation, Compliance, and Safety (EHS) to our clients. You will have the opportunity to work with a variety of Subject Matter Experts (SMEs) on a diverse range of projects and technologies. With our commitment to client satisfaction and our global team of experienced professionals, Trinity’s Life Sciences Division offers an exciting and rewarding career opportunity for individuals passionate about making a positive impact on patients’ lives and public health across the globe.

The Project Manager will lead and deliver technical projects within life science, including pharmaceutical, biotech, and laboratory environments. This role involves managing capex from concept and design through procurement, construction, commissioning, and turnover; as well as projects that are smaller in value on behalf of our clients. The Project Manager will coordinate cross-functional teams, ensuring alignment with GMP, FDA, and client-specific requirements.

Responsibilities include providing both technical and management insight, including managing project scope, schedule, budget, and risk, while maintaining strict compliance with safety and quality standards. as well as technical advisory and insight on project execution and delivery. The ideal candidate will possess strong communication and problem-solving skills, with the ability to interface with clients, contractors, and all stakeholders. Additionally, the individual would have large and complicated projects that also required the candidate to provide technical and engineering input.

• Manage equipment procurement and project execution activities for sterile manufacturing systems and supporting infrastructure.
• Coordinate equipment vendors, engineering firms, procurement teams, consultants, and internal stakeholders to support timely project delivery.
• Develop, maintain, and communicate project schedules, milestone trackers, risk registers, and action item logs.
• Monitor vendor performance, identify schedule risks, and proactively implement mitigation and recovery plans.
• Lead regular project review meetings and provide concise status updates to project leadership.
• Facilitate cross-functional collaboration among Engineering, Manufacturing, Quality Assurance, Validation, Supply Chain, and external partners.
• Track project deliverables from design review through Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and handover.
• Drive issue resolution and decision-making to maintain project timelines and achieve project objectives.
• Ensure effective communication and alignment among all project stakeholders.
• Support resource planning and coordination across project phases.
• Demonstrate ownership and accountability for assigned project deliverables.
• Support regulatory compliance activities by coordinating documentation, quality requirements, and stakeholder inputs in accordance with GMP, FDA, and client-specific expectations.

• Bachelor’s degree (B.S.) in Life Science related field from four-year college or university or foreign equivalent; and at least five years of related experience as a PM within the Life Science industry.
• Candidate ideally would have a minimum of 10+ years of experience in Engineering and Project Management within the Life Science sector.
• Previous project management experience in cGMP environment is an asset to this role. Experience in consulting in Life Science industry and delivering successful large-scale Engineering projects.
• Project management certification.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Individual has…