Packaging Engineer – Hybrid (#2377)

Packaging Engineer – Hybrid

Diversity, Equity & Inclusion

We are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

Purpose:

We are seeking an Associate Packaging Engineering to support North America Group packaging commercialization efforts for their U.S. OTC and Rx business. Based in Princeton, NJ (Hybrid work schedule) this role will report to Manager Packaging Engineering

Responsibilities:

• Provide necessary support to Rx External Manufacturing production at various CMO sites
• Qualification of primary and secondary/tertiary packaging systems. Execute testing as needed to support development and submission activities: USP testing; extractables & leachable; shipping tests; child resistance; line and component validation. Provide critical inputs and requirements for product stability and FDA and other agency submissions. Author, review, and coordinate approvals for documentation to support all activities as needed
• Provide packaging structural engineering, development and design support
• Coordinate structural and artwork development process with graphic designers for new SKU development, commercial launches, and manage routine artwork changes
• Initiate and execute primary and secondary package design projects
• Maintain packaging database. Create and edit as needed packaging documentation including pBOM and specifications. Develop dielines for artwork working with the manufacturing facilities
• Initiate change control for packaging related changes at CMO. Review and approve packaging documentation as needed to support CMO activities
• Manage projects related to new product launch packaging activities, facilities and manufacturing changes
• Manage suppliers and co-packers. Provide packaging oversight for activities and troubleshoot as necessary for startup, new product or SKU launches and support on-going production

Qualifications / Skills:

• BS degree in Engineering (Packaging preferred, Mechanical, Materials Science)

• 4-10 years of experience in regulated industry (pharmaceutical or consumer products packaging with Rx packaging preferred)

• The candidate should have experience with variety of packaging on both primary (bottles, closures, blisters, pouches) and secondary/tertiary packaging (cartons, labels, shippers, displays). Device or combination product experience a plus

• Experience with cGMP’s, all applicable FDA guidelines and Quality Systems. Experience with PPPA/CPSIA regulations and compliance. Prefer additional understanding of ISO, USP, ISTA, ASTM standards

• Comfortable working in a team environment with tight deadlines

• Experience in packaging operations is desired

• Excellent communication, technical writing, and presentation skills

• Must be onsite 3 days per week

• Domestic travel may be required: up to 20% – 30%

Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

Need 2-3 years of relevant exp looking for someone either in cosmetic / generic industry – bottling, caps, etc

COVID-19 Vaccination

At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future. Weekly COVID testing is mandatory for all employees who have not uploaded proof of vaccination or who are not fully vaccinated.

Equal Opportunity Employer:

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

PRECISION LIFE SCIENCES