Job Details

We are looking for a Packaging Engineer I who will interface with vendors to develop alternate designs of packaging components and translate into actionable specs.

Responsibilities

• Lead packaging development activities for clinical programs, ensuring alignment with product requirements, regulatory expectations, and global standards.
• Apply sound engineering principles and industry standards (e.g., USP, ISO, ASTM) to the design and qualification of container closure systems (CCS).
• Author and execute packaging studies, including protocols and reports for component qualification, shipping validation, and compatibility assessments.
• Conduct and support equipment and process qualification activities (IQ/OQ/PQ) for packaging lines and configurations at internal and external manufacturing sites.
• Ensure packaging components and systems comply with current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines.
• Investigate and resolve packaging-related deviations, non-conformances, and complaints in collaboration with Quality and Operations teams.
• Support regulatory submissions by authoring and reviewing relevant sections of INDs, NDAs, BLAs, and other global filings.
• Maintain and author SOPs related to packaging development and ensure alignment with broader organizational procedures.
• Collaborate with external partners including CMOs, suppliers, and test laboratories to ensure timely and compliant execution of packaging activities.
• Travel up to 25% may be required to support project execution at external sites.
• With guidance may participate on cross-functional project teams, to help meet complex project deliverables such as new product launches or start-up of new manufacturing/packaging sites.
• With guidance, performs fairly routine tasks to aid technical investigations and assessment of deviations, particularly as related to data generation/gathering and analysis.
• Prepares required engineering and manufacturing documentation, for revision and approval by manager/supervisor.
• Works on assigned projects through completion with limited direct supervision. Interfaces with production sites to improve/optimize current production processes.

Basic Qualifications

• Master's OR
• Bachelor's and 2+ years of relevant experience OR
• Associate and 4+ years of relevant experience OR
• High School Diploma/GED and 5+ years of relevant experience

Preferred Qualifications

• Good verbal, written, and interpersonal communication skills are required.
• Normally receives limited instructions on routine work and general instructions on new assignments.
• Works on problems of a routine to basic scope where analysis of data requires evaluation of identifiable factors.
• Specific education and experience requirements: BS or MS degree in a science field, preferably in an engineering field or a related technical discipline.