Associate Packaging Engineer

Job Description

We are seeking a highly motivated and detail-oriented Associate Packaging Engineer to join our Packaging Development team. This entry-level position is ideal for a recent graduate eager to begin a career in the pharmaceutical, biologics, and combination product industry. The successful candidate will contribute to the design, development, and qualification of packaging systems that ensure product protection, patient safety, and compliance with global regulatory standards. This role offers hands-on experience across the product lifecycle—from early-phase clinical development through commercial launch.

Key Responsibilities:

• Serve as a Packaging Development representative on cross-functional product development teams, supporting container closure system selection and development from Phase 1 through commercial transfer.
• Collaborate with internal stakeholders and external contract manufacturing organizations (CMOs) to coordinate clinical packaging operations and provide technical support, including on-site troubleshooting.
• Assist in the evaluation, characterization, and qualification of primary, secondary, and tertiary packaging components (e.g., vials, stoppers, syringes, blisters, bottles, caps, cartons, trays, shippers).
• Design, author, and execute packaging development protocols, test plans, and technical reports in accordance with internal procedures and regulatory expectations.
• Support packaging equipment and process qualifications (IQ/OQ/PQ) and participate in packaging line trials under supervision.
• Conduct hands-on testing and documentation activities in the packaging development laboratory, including sample preparation and data collection.
• Author and maintain packaging specifications, bills of materials (BOMs), and other technical documentation within document control systems.
• Support regulatory submissions by providing packaging-related documentation and data for INDs, NDAs, BLAs, and other filings.
• Participate in risk assessments (e.g., FMEA) related to packaging systems and processes.
• Assist in change control activities related to packaging components and specifications.
• Support sustainability initiatives by evaluating and recommending environmentally responsible packaging solutions.
• Maintain compliance with internal quality systems and participate in audits or inspections as needed.
• Travel to CMOs, suppliers, and other sites as needed to support packaging operations, qualifications, and issue resolution.

Basic Qualifications:

• Bachelor’s OR
• Associate and 2+ years of relevant experience OR
• High School Diploma/GED and 3+ years of relevant experience

Preferred Qualifications:

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related scientific discipline.
• Strong foundational knowledge of packaging principles, materials, and engineering practices.
• Excellent written and verbal communication skills, with the ability to produce clear, concise, and accurate technical documentation.
• Proficiency in Microsoft Office and familiarity with document management systems.
• Strong organizational skills and attention to detail.
• Familiarity with FDA regulations, current Good Manufacturing Practices (cGMP), and United States Pharmacopeia (USP) standards.
• Interest in and basic proficiency in Computer-Aided Design (CAD) tools.
• Familiarity with design controls and human factors engineering principles.
• Exposure to materials science, thermal testing, or transport simulation methods is beneficial.
• Experience with labeling development and serialization requirements is a plus.
• Basic understanding of ISO 11607, ICH guidelines, or EU MDR is helpful.
• Ability to work effectively in a team-oriented, fast-paced environment.

Preferred Attributes:

• Eagerness to learn and grow within a regulated industry.
• Collaborative mindset with a proactive approach to problem-solving.
• Willingness to travel and engage with cross-functional teams and external partners.