Serialization Engineer - Packaging Operations at CONTRACT PHARMACAL CORP

Town of Smithtown, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

100000.0

Posted On

21 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Serialization, Packaging Engineering, Equipment Commissioning, Validation, Process Optimization, Serial Number Management, EPCIS, Technical Writing, SOP Development, AutoCAD, MS Excel, MS Project, DSCSA Guidelines, cGMP, FDA Compliance, 21 CFR Part 11

Industry

Pharmaceutical Manufacturing

Description

Description 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. Job Type: Full-Time Location: Hauppauge, NY Works Hours: Monday – Friday, 9:00AM – 5:00PM Pay Range: $75,000 - $100,000 per year, depending on experience Start Date: ASAP What makes this role exciting: 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. Why Join CPC? 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. We pride ourselves 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 Responsibilities In this role, you will: 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. Education & Experience 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 Skills, Knowledge & Abilities 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

Responsibilities

The Serialization Engineer will support packaging operations by managing equipment commissioning, validation, and process optimization from inception to commercial launch. They will also administer serialization operations, including serial number management and the development of technical documentation to ensure regulatory compliance.