Process Engineer

Process Engineer

Location:

Bronx, NY, US, 10457 At Perrigo, we are driven by our mission to Make Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust.

We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview The Process Engineer provides technical and scientific support for commercial prescription (Rx), over-the-counter (OTC), and cosmetic topical products. This role collaborates closely with Regulatory Affairs, Quality, Research & Development, Operations, and Legal teams to develop, optimize, transfer, and validate manufacturing processes. The Process Engineer is responsible for supporting product scale-up activities, evaluating manufacturing and product performance, investigating deviations and product failures, and implementing effective corrective and preventive actions to ensure product quality, compliance, and operational excellence.

Scope of the Role Conduct technical assessments and provide ongoing process support for commercial Rx, OTC, and cosmetic topical products to ensure quality, efficiency, and compliance. Lead technology transfer activities for newly developed products and transferred manufacturing processes from R&D or external manufacturing sites into commercial operations, ensuring successful scale-up and implementation. Develop, optimize, and implement manufacturing processes for new, existing, reformulated, and transferred products to improve process robustness, efficiency, and product quality.

Investigate manufacturing issues, process deviations, and product failures; perform root cause analyses and recommend corrective and preventive actions (CAPAs). Review, revise, and maintain Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, cleaning procedures, and associated documentation to support regulatory compliance and continuous improvement initiatives. Perform laboratory-scale formulation and process development studies to support process optimization, troubleshooting, and scale-up activities. Evaluate process performance data and identify opportunities for process improvements, cost reduction, and increased manufacturing efficiency.

Support Material Review Board (MRB) activities, including the review and disposition of nonconforming materials and products. Participate in Process Excellence Management (PEM), Process Performance Qualification (PPQ), Continued Process Verification/Validation (CPV/CV), and other validation activities to ensure processes remain in a state of control. Collaborate closely with Regulatory Affairs, Quality Assurance, Research & Development, Operations, and Legal teams to support product lifecycle management and maintain compliance with cGMP and FDA requirements.

Prepare technical reports, protocols, investigations, and supporting documentation required for process changes, validation activities, and regulatory submissions. Manage multiple projects simultaneously while meeting established timelines and business objectives.

Experience Required Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Pharmaceutical Engineering, Chemistry, or a related scientific discipline. 2–5 years of pharmaceutical manufacturing, process engineering, technical services, or process support experience in a regulated environment. Strong understanding of pharmaceutical manufacturing processes, pharmaceutical sciences, and process engineering principles. Knowledge of cGMP requirements, FDA regulations, and pharmaceutical quality systems. Excellent interpersonal, organizational, and communication skills, with the ability to collaborate…