Process Engineer

Join a great team that is working to target cancer from the inside out! The Process Engineer will provide technical support for GMP drug product manufacturing operations. This role will provide technical support and conduct investigations into product/process quality events and customer complaints; identify, assess, and execute projects to optimize existing processes, raw materials, components, and packaging in manufacturing and final product packaging;

work with multi-functional teams to execute and deliver assigned projects, including specification, conceptual development, protocol writing, selection, testing, and qualification. This is a hybrid role, based part-time in the office and part-time remote, with the office located in Somerset, NJ.

• Identify opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection. Evaluate those opportunities and present projects to management for approval to implement changes.
• Work with multi-functional teams to execute product and packaging projects to improve and optimize manufacturing and packaging processes. Support complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities.
• Provide technical support for the transfer of new or improved manufacturing processes between functional groups or sites, ensuring knowledge capture and compliance with quality and regulatory standards.
• Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department.
• Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term, and future needs. Lead root-cause analysis investigations as a technical resource.
• Investigate product complaints and write reports of investigations. Assist as required to support conclusion and possible corrective actions.
• Provide support in the development, review, and maintenance of various radiopharmaceutical and cGMP documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions and technical documents.
• Assist in the development of training materials and conduct training sessions for target audience on document updates, providing clarity and guidance, ensuring full compliance.
• Present data and information as a technical subject matter expert to regulatory agencies.
• Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
• Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers.
• Stay up to date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.

• Bachelor’s Degree in Engineering or related scientific discipline with a minimum 2+ years of experience in pharmaceutical or medical device manufacturing or other related regulated industry.
• Expert knowledge of MS Office suite.
• Previous experience working with radiopharmaceuticals and CMOs strongly preferred.
• Must possess excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external.
• Self‑starter with the ability to work well both independently and in a team environment.
• Demonstrated technical problem‑solving skills with root cause analysis tools.
• Direct experience with project management skills.
• Excellent organizational and time management skills.
• Establishes strong inter‑departmental relationships and is viewed as a valuable technical resource to others.
• Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies.
• Familiar with Code of Federal Regulations (CFR) parts 210 and 211 and supporting regulatory inspections.
• Exp…