Serialization Engineer - Packaging Operations

CONTRACT PHARMACAL CORP•Town of Smithtown, NY

6d•$75,000 - $100,000•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.

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
Hands-on experience with packaging equipment, line trials, and process validation strongly preferred
Experience with AutoCAD, MS Excel, MS Project, or other engineering software
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 with cutting-edge serialization technology – work directly with Optel Linemaster, Pharmaproof, and other packaging automation systems.
Learn and grow in a fast-paced pharmaceutical environment – gain exposure to packaging design, commissioning, validation, and regulatory compliance.
Cross-functional experience – collaborate with Engineering, Quality, Project Management, and technical teams to see projects from concept to commercial launch.
Impactful work – your contributions directly support product integrity, consumer safety, and regulatory compliance.

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.