Project Engineer
$100,000–$130,000 year
On-site · Raritan, New Jersey, United States
Job Summary
Project Engineer for Operations Readiness to support CQV, commissioning, qualification, validation, and startup across biologics and cell-therapy projects. Serves as a liaison between Engineering, CQV, Manufacturing, Quality, and Facilities to ensure systems, equipment, procedures, and personnel are prepared for compliant, on-time operations. Responsibilities include coordinating readiness activities, maintaining integrated project schedules, tracking and mitigating risks, overseeing CQV readiness, managing scope changes and readiness impacts, developing cost estimates, and delivering project status reports and dashboards in a cGMP environment. The role is onsite at the client’s site in Raritan, NJ, and requires strong cross-functional collaboration, vendor coordination, and effective communication.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related technical discipline (or equivalent experience)
- 3–7 years of project engineering, project management, CQV, or operations readiness experience in pharmaceutical or biopharmaceutical manufacturing environments
- Experience coordinating vendors, contractors, and internal stakeholders to deliver scope on time and within budget
- Strong communication, stakeholder management, and decision-making skills
- Experience facilitating or actively participating in meetings and driving alignment in regulated environments
- Proven understanding of CQV lifecycle and its integration with manufacturing and operational readiness
- Solid knowledge of cGMP requirements, engineering lifecycles, and pharmaceutical quality systems
- Experience working cross-functionally with engineering, manufacturing, quality, and facilities/maintenance teams
- Experience in biologics and/or cell therapy manufacturing environments (preferred)
- Hands-on experience with project scheduling and reporting tools (e.g., MS Project, Primavera, Smartsheet, Power BI, or similar)
- Soft Skills: proactive, resourceful, and able to manage multiple projects and priorities
Desired Qualifications
- Experience coordinating cross-functional teams
- Strong communication and stakeholder management skills
- Experience with CQV (commissioning, qualification, validation)
- Knowledge of cGMP
- Project scheduling and reporting
- Vendor and contract management
- Ability to work onsite in a regulated manufacturing setting
- Biopharmaceutical or cell therapy manufacturing experience (preferred)
- Tech transfer or late-stage capex project experience (preferred)
- ISPE Good Practice Guides familiarity (preferred)
- MS Project/Primavera/Smartsheet/Power BI (preferred)
- Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent)
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