Project Manager

Trinity Consultants - Advent Engineering; Delaware; On-site; USD 110,000 - 160,000; Full time

Job summary

Trinity Consultants in its Life Sciences division seeks a Project Manager to lead and deliver technical projects in pharma, biotech, and laboratory environments. You will manage capex from concept through procurement, construction, commissioning, and turnover, aligning with GMP, FDA, and client requirements.

You will coordinate cross-functional teams, manage scope, schedule, budget, and risk, and provide technical and managerial guidance to clients, contractors, and stakeholders.

Qualifications

• Bachelor's degree in Life Science and at least five years of PM experience in Life Science.
• 10+ years of experience in Engineering and Project Management within Life Science.
• Experience in consulting in Life Science industry and delivering large-scale projects.
• Project management certification.

Responsibilities

• 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 implement mitigation 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 FAT, SAT, commissioning, qualification, and handover.
• Drive issue resolution and decision-making to maintain timelines and objectives.
• Ensure effective communication and alignment among all project stakeholders.
• Support regulatory compliance activities by coordinating documentation and quality requirements per GMP and FDA.

Skills

Project management

GMP

FDA compliance

Stakeholder communication

cGMP

Education

Bachelor’s degree in Life Science related field

Project management certification

Job description

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.

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.

EDUCATION and/or EXPERIENCE

• 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.

QUALIFICATIONS

• 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 experience in consulting environment and engaging clients in projects that may have a dynamic schedule while multi-tasking other responsibilities.

Preferred Qualifications:

• 7+ years of experience in project or program management within the biotech, pharmaceutical, or life sciences industries.
• Experience with automated vial inspection systems.
• Strong background in engineering, utilities, and capital project execution in a GMP-regulated environment.
• Demonstrated ability to lead complex, multi-disciplinary projects for greenfield projects.

SUPERVISORY RESPONSIBILITIES

May directly supervise a number of non-supervisory employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Why Join?

• Immediate opportunity to make an impact at a large-scale biotech/pharmaceutical manufacturing facility.
• Work on cutting-edge automation and digital transformation initiatives.
• Collaborative environment with engineering, manufacturing, quality, and IT teams.
• High-visibility role supporting critical manufacturing operations.