Project Manager, Pharma Engineer, Pharmaceutical Manufacturing

Job Title: Project Manager – Sterile Injectables Technical Transfer

Location: Onsite – New Jersey, United States

Employment Type: Contract (W-2)

Duration: 12+ Months

$45.00–$55.00 per hour (W-2)

In accordance with applicable pay transparency laws, the compensation range listed is a good-faith estimate of the hourly rate for this position at the time of posting. Actual compensation may vary based on factors including, but not limited to, experience, skills, education, certifications, geographic location, and other business-related considerations.

This is a contract position. No employer-provided benefits are offered unless otherwise specified in a written employment agreement.

We are seeking an experienced Project Manager – Sterile Injectables Technical Transfer to lead technical transfer activities for commercially approved sterile injectable pharmaceutical products. This role is responsible for managing end-to-end transfer projects involving pre-filled syringes, vials, and pre-filled cartridges, ensuring transfer readiness, process validation, PPQ execution, and successful commercialization. The position requires strong project management capabilities, technical expertise in sterile manufacturing, and the ability to collaborate effectively across cross-functional teams.

• Lead and manage end-to-end technical transfer projects for commercially approved sterile injectable pharmaceutical products.
• Develop, maintain, and execute Technical Transfer Plans, including work breakdown structures (WBS), project schedules, timelines, risk assessments, and gap assessments.
• Coordinate transfer readiness activities, process validation efforts, and Process Performance Qualification (PPQ) execution.
• Collaborate with Manufacturing, Manufacturing Science and Technology (MS&T), Quality, Regulatory Affairs, Validation, Engineering, Supply Chain, Operations, and other stakeholders to support project objectives.
• Monitor project scope, timelines, deliverables, and risks while ensuring timely communication to stakeholders and leadership.
• Identify, assess, and mitigate project risks and proactively address issues that may impact project execution.
• Maintain project documentation, status reporting, and tracking using Smartsheet and other project management tools as required.
• Support compliance with applicable GMP requirements, aseptic processing standards, validation protocols, change control procedures, and internal quality systems.
• Manage multiple concurrent projects while maintaining quality, compliance, and operational objectives.
• Facilitate project meetings and provide regular progress updates to leadership and cross-functional teams.

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related scientific or technical discipline.
• Minimum of five (5) years of experience in sterile injectable pharmaceutical manufacturing, MS&T, technical operations, or a related function.
• Minimum of three (3) years of direct experience leading sterile injectable technical transfer projects.
• Demonstrated experience supporting the transfer of commercially approved sterile injectable pharmaceutical products.
• Experience with pre-filled syringes, vials, and/or pre-filled cartridges.
• Strong understanding of aseptic processing, sterile manufacturing operations, process validation, PPQ, change control, and GMP requirements.
• Experience developing and managing Technical Transfer Plans, WBS documentation, schedules, risk assessments, gap assessments, and execution plans.
• Advanced proficiency with Smartsheet.
• Strong project leadership, organizational, communication, and stakeholder management skills.
• Ability to work independently and effectively manage multiple priorities and projects simultaneously.

• Project Management Professional (PMP) certification.
• Additional experience supporting large-scale manufacturing transfers, product launches, or commercialization initiatives within regulated pharmaceutical environments.
• Experience working within FDA-regulated sterile manufacturing facilities.

• Ability to work onsite at the designated New Jersey location.
• Ability…