Serialization Engineer - Packaging Operations

CONTRACT PHARMACAL CORP • Town of Smithtown, NY

just now • Onsite

About The Position

We are seeking a Serialization Engineer to join our Operations team, where you’ll play a key role in supporting serialized packaging operations and technical packaging solutions across pharmaceutical products. In this hands-on, cross-functional role, you’ll work closely with Packaging, Quality, Engineering, and project teams to ensure efficient, compliant, and accurate packaging operations from inception through commercial launch. This is an excellent opportunity for someone who enjoys solving technical challenges, learning new serialization technologies, and contributing directly to high-quality pharmaceutical packaging processes. This role offers hands-on experience with cutting-edge serialization technology, working directly with Optel Linemaster, Pharmaproof, and other packaging automation systems. You will learn and grow in a fast-paced pharmaceutical environment, gaining exposure to packaging design, commissioning, validation, and regulatory compliance. The position involves cross-functional collaboration with Engineering, Quality, Project Management, and technical teams to see projects from concept to commercial launch, with contributions directly supporting product integrity, consumer safety, and regulatory compliance. At CPC, you’ll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. CPC prides itself on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact.

Requirements

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical discipline required
• Minimum 3 years of relevant experience in engineering, packaging or serialization roles, preferably in a pharmaceutical environment
• Knowledge of Pharmaceutical Serialization and Aggregation systems and DSCSA guidelines
• Familiarity with FDA, cGMP, and 21 CFR Part 210, 211, and Part 11
• Strong technical writing and documentation skills
• Hands-on knowledge of packaging equipment setup, operation, and maintenance
• Ability to read and develop engineering drawings, P&IDs, and technical documentation
• Strong problem-solving skills and ability to work in cross-functional teams

Nice To Haves

• Hands-on experience with packaging equipment, line trials, and process validation strongly preferred

Responsibilities

• Support serialized packaging projects from start to launch by assisting in equipment commissioning, validation, and process optimization for new and existing packaging configurations.
• Conduct line trials, studies, and assessments to determine critical process parameters (CPP) and ensure consistent, compliant packaging operations.
• Administer serialization operations including serial number management, master recipe creation, EPCIS updates, and shipment event notifications.
• Collaborate cross-functionally with Packaging, Engineering, Quality, Project Management, and Business Development teams to solve technical challenges and implement process improvements.
• Develop and maintain technical documentation including SOPs, setup sheets, P&IDs, and packaging engineering reports to support compliance and operational excellence.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees