Senior Process Development Engineer - Packaging Equipment

Senior Process Development Engineer – Packaging Equipment Onsite The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio. This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands. Key Functions & Outputs Act as site expert in automated/semi-automated packaging equipment and device assembly. Lead equipment characterization to optimize operating conditions and to establish appropriate process parameters, operating ranges, and controls. Lead commissioning, qualification, and validation (CQV) of GMP equipment. Own protocols, reports, risk assessments and other technical documentation Support technical transfer of product portfolio into the Ohio site. Drive continuous improvement in device assembly and packaging line capacity/performance. Communicate across the network to deliver technical milestones. Analyze, design, and implement manufacturing/business process improvements. Drive productivity, throughput, and efficiency gains. Able to author and manage various documents/protocols/reports Deviation/CAPA/EV Owner Change Control Owner Build networks with commercial and clinical operations. Provide support for equipment standardization, troubleshooting, and performance trending Preferred Combination product assembly equipment expertise End to end integrated packaging equipment Hands of experience with euipment to establish parameters Cross-functional project leadership experience Strong teamwork and communication skills Direct experience in devices, combination products, and packaging operations Supplier management experience (FDP equipment vendors) Adaptability in regulated, fast-paced environments Operational excellence / continuous improvement mindset Pay range is $39 - $44 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience. At Crystal Equation, we empower people and advance technology initiatives by building trust. We will serve to empower you along the way and provide the path for your professional journey. For more information regarding our Privacy Policy, please visit crystalequation.com/privacy. #J-18808-Ljbffr Crystal Equation Corporation