Packaging Process Engineer I

Catalent•Greenville, NC

3d•Onsite

About The Position

Packaging Process Engineer I Position Summary Work Schedule: Monday to Friday during regular business hours 100% based on-site in Greenville, NC Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Packaging Process Engineer I oversees the development, coordination, and continuous improvement of packaging solutions across production operations. Serving as a technical bridge between internal teams, clients, and vendors, it drives requirement gathering, packaging design, and implementation on production equipment. The Role Lead the translation of customer and project requirements into robust, compliant packaging solutions by partnering with clients, internal teams, and vendors; provide technical guidance throughout project scoping, packaging design, and implementation Drive the development, optimization, and continuous improvement of primary, secondary, and tertiary packaging components, including blister formats, container/closure systems, labeling, and cartons—ensuring fit for purpose designs that meet regulatory and product needs Support efficient packaging operations by assisting with equipment setup, qualification, troubleshooting, and serialization activities, identifying root causes of issues, and implementing corrective actions to enhance equipment reliability and line performance Author, maintain, and execute GMP ‑ compliant engineering documentation, batch record inputs, work instructions, and quality system records while utilizing electronic systems (e.g., TrackWise, EDMS, ComplianceWire) to support investigations, change control, deviations, CAPAs, and training Collaborate cross functionally with Production, Quality Assurance, Validation, Supply Chain, and Facilities to ensure alignment on packaging requirements, operational readiness, and continuous improvement of packaging processes and workflows Manage vendor interactions—including component design, technical evaluations, pricing discussions, and FAT/SAT activities—to ensure timely, cost-effective, and high-quality solutions Support thorough and compliant investigations through structured problem solving and root cause analysis, driving improvements that enhance product quality and packaging integrity Monitor industry trends, materials, and technologies to identify opportunities for innovation, efficiency gains, and standardization across packaging engineering activities Contribute to project execution by tracking milestones, documentation, and deliverables while helping maintain internal tools such as blister format libraries and equipment documentation Other duties assigned

Requirements

Master’s degree in Engineering discipline (e.g. Packaging Mechanical, Chemist, Industrial, or related) OR Bachelor’s degree in Engineering discipline with 2+ years of experience in the pharmaceutical industry or regulated manufacturing industry required
Foundational understanding of pharmaceutical packaging operations, including serialization processes
Working knowledge of cGMPs, applicable industry standards, and regulatory guidelines
Basic understanding of federal and local health and safety regulations relevant to manufacturing and packaging environments
Ability to lift objects weighing 40 pounds without assistance
Ability to use hands for repetitive simple grasping and fine motor manipulation
Ability to bend, squat, reach, and push as required by job duties
Ability to stand and remain on feet for extended periods of time
Ability to work safely with hazardous chemicals and active chemical ingredients
This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.

Nice To Haves

Degree in Packaging Sciences strongly preferred

Responsibilities

Lead the translation of customer and project requirements into robust, compliant packaging solutions by partnering with clients, internal teams, and vendors; provide technical guidance throughout project scoping, packaging design, and implementation
Drive the development, optimization, and continuous improvement of primary, secondary, and tertiary packaging components, including blister formats, container/closure systems, labeling, and cartons—ensuring fit for purpose designs that meet regulatory and product needs
Support efficient packaging operations by assisting with equipment setup, qualification, troubleshooting, and serialization activities, identifying root causes of issues, and implementing corrective actions to enhance equipment reliability and line performance
Author, maintain, and execute GMP ‑ compliant engineering documentation, batch record inputs, work instructions, and quality system records while utilizing electronic systems (e.g., TrackWise, EDMS, ComplianceWire) to support investigations, change control, deviations, CAPAs, and training
Collaborate cross functionally with Production, Quality Assurance, Validation, Supply Chain, and Facilities to ensure alignment on packaging requirements, operational readiness, and continuous improvement of packaging processes and workflows
Manage vendor interactions—including component design, technical evaluations, pricing discussions, and FAT/SAT activities—to ensure timely, cost-effective, and high-quality solutions
Support thorough and compliant investigations through structured problem solving and root cause analysis, driving improvements that enhance product quality and packaging integrity
Monitor industry trends, materials, and technologies to identify opportunities for innovation, efficiency gains, and standardization across packaging engineering activities
Contribute to project execution by tracking milestones, documentation, and deliverables while helping maintain internal tools such as blister format libraries and equipment documentation
Other duties assigned