Engineer Senior

Engineer Senior Top 3 Must Have Skill Sets GMP & Packaging Equipment Expertise Strong hands‑on experience in GMP‑regulated environments Direct experience with packaging / device assembly equipment (automated or semi‑automated) Involvement in commissioning, qualification, and validation (CQV) Technical Writing & Document Management Systems Proven ability to author and manage GMP documents (protocols, reports, validation docs) Experience with document management systems (preferably KNEAT or Veeva) Ownership of deviations, CAPAs, and change controls Process Development & Continuous Improvement Ability to analyze and optimize manufacturing processes Experience driving efficiency, throughput, and performance improvements Strong technical leadership in process/equipment optimization Strong project management and team player skillset. Ability to work within different cross‑functional groups and coordinate projects. Nice to have: Kneat/Veeva and former experience managing projects Red Flags Weak or No GMP Experience Lack of Hands‑On Equipment Experience Poor Technical Writing / Documentation Skills No Process Improvement Mindset Limited Ownership or Leadership Weak Communication & Cross‑Functional Skills Inflexibility with Schedule or On‑Site Work Summary 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 ability to work a flexible schedule based on operation demands and both on‑site work and ~10% travel. Responsibilities Equipment & Manufacturing Support: Provide on‑site support for GMP packaging and device assembly operations Troubleshoot equipment issues and improve reliability/performance Support automated and semi‑automated assembly lines Monitor and trend equipment performance metrics Process Improvement & Optimization: Identify and implement process improvements to increase throughput and efficiency Analyze manufacturing data to drive continuous improvement initiatives Optimize packaging line capacity and performance Documentation & Quality Systems: Write, review, and manage GMP documents (protocols, reports, procedures) Own and manage deviations, CAPAs, and change controls Maintain and update the site master validation plan Use systems like KNEAT or Veeva for document control Validation & Technical Projects (CQV): Lead or support commissioning, qualification, and validation (CQV) activities Support tech transfer of products into the Ohio site Ensure equipment and processes meet regulatory and quality requirements Cross‑Functional Collaboration: Work with manufacturing, quality, engineering, and external vendors Coordinate with commercial and clinical teams Communicate progress on technical milestones and projects Project & Vendor Management: Support equipment‑related projects and timelines Interface with equipment suppliers/vendors for troubleshooting and improvements Contribute to standardization efforts across sites Flexible Operations Support Work swing shifts (day/night/weekend as needed) Provide support based on production demands Occasional travel (~10%) Project Management 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. Technical Leadership Act as site expert in automated/semi‑automated device assembly. Lead commissioning, qualification, and validation (CQV) of GMP equipment. Own and maintain the site master validation plan. Operational Excellence Analyze, design, and implement manufacturing/business process improvements. Drive productivity, throughput, and efficiency gains. Quality and Document Management Systems Able to author and manage various documents/protocols/reports Deviation/CAPA/EV Owner Change Control Owner Relationships Build networks with commercial and clinical operations. Provide support for equipment standardization, troubleshooting, and performance trending Qualifications Basic (Education & Experience) Doctorate (no experience required) OR Master’s + 2 years GMP experience OR Bachelor’s + 4 years GMP experience OR Associate’s + 8 years GMP experience OR High School/GED + 10 years GMP experience Preferred Combination product assembly equipment expertise 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 $34 - $39 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience. #J-18808-Ljbffr Crystal Equation Corporation