Project Engineer

Technical Source is seeking an Operations Readiness Project Engineer to support biopharmaceutical and pharmaceutical manufacturing clients through late-stage project execution, startup, and operational handover in Raritan, NJ. This role is embedded within our clients Outsourced Technical Services (OTS) model and is accountable for driving integrated readiness across commissioning, qualification, validation (CQV), manufacturing, quality, and facilities teams. Outsourced Technical Services (OTS) is an integral part of our clients’ ability to support clients across the complete project life cycle. We have over 50 years’ industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting our clients ongoing expansion in the US.

The successful candidate will support cross-functional readiness activities, manage risk and schedule, and ensure systems, equipment, and processes are prepared to transition into compliant, on-time operations.

Responsibilities

• Support operational readiness planning and execution across commissioning, qualification, validation, manufacturing, and quality functions.
• Manage external contractors, equipment vendors, and internal stakeholders to ensure readiness activities are completed on schedule, within scope, and aligned to budget.
• Own and maintain integrated project schedules, including CQV milestones, interdependencies, and resource constraints.
• Identify, track, and mitigate project and operational readiness risks, supporting contingency and recovery planning as required.
• Coordinate and oversee commissioning, qualification, and validation readiness, ensuring systems and equipment meet regulatory and operational requirements.
• Manage scope changes and readiness impacts to ensure original project and startup objectives are maintained.
• Develop cost estimates and forecasts related to readiness activities, including labor, vendor support, and supporting services.
• Prepare and deliver project status reports, dashboards, and executive presentations.
• Act as a primary interface between Engineering, CQV, Manufacturing, Quality, and Facilities teams to support a smooth handover to operations.
• Facilitate readiness reviews, risk workshops, and cross-functional meetings in a cGMP environment.
• Support PM Group OTS governance, reporting standards, and client engagement expectations.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (or equivalent experience).
• 3-7 years of project management experience in biopharmaceutical or pharmaceutical manufacturing environments.
• Proven experience supporting operations readiness, startup, or late-stage project delivery.
• Strong understanding of commissioning, qualification, and validation lifecycles and their integration with manufacturing readiness.
• Solid knowledge of cGMP requirements, engineering lifecycles, and pharmaceutical quality systems.
• Familiarity with ISPE Good Practice Guides and structured project management methodologies.
• Demonstrated ability to manage complex, cross-functional teams and vendor partners.
• Excellent communication, stakeholder management, and decision-making skills.
• Experience facilitating meetings and driving alignment in regulated environments