Sr Packaging Engineer I

Job Description

The Senior Packaging Engineer I serves as a technical leader within the Package Development team, responsible for the design, qualification, and implementation of packaging systems supporting Gilead’s pharmaceutical and biologics pipeline. This role is essential for developing packaging solutions for combination products, device-integrated therapies, and temperature-sensitive and conventional dosage forms. The successful candidate will bring strong expertise in packaging engineering, regulatory compliance, and cross-functional collaboration to ensure packaging systems meet product, patient, and global regulatory requirements.

Specific Job Requirements

• Lead the development and qualification of primary, secondary, and tertiary packaging systems for oral solids, parenteral, biologics, and combination products.
• Apply advanced principles related to container closure systems (CCS) and drug/device secondary packaging, ensuring robust design and operational performance.
• Manage packaging activities across clinical development and commercialization, ensuring timely execution and compliance with cGMP and regulatory standards.
• Support combination product packaging, demonstrating familiarity with design controls, risk management, and applicable regulations (e.g., 21 CFR Part 4, ISO 11607).
• Manage material selection, component characterization, and qualification of packaging systems and equipment.
• Execute equipment and process qualification (IQ/OQ/PQ) for packaging configurations and manufacturing sites.
• Design and author packaging study protocols and technical reports to support product development, stability, and regulatory submissions.
• Draft and review Standard Operating Procedures (SOPs) related to packaging development and departmental functions, ensuring alignment with broader organizational policies.
• Contribute to global regulatory filings by authoring packaging-related sections for INDs, NDAs, BLAs, and other submissions.
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Device Engineering, and external partners to develop and implement optimal packaging solutions.
• Monitor industry trends, emerging technologies (e.g., sustainable packaging), and evolving regulatory requirements.
• Participate in standards organizations (e.g., USP, ISO, ASTM, ISTA) and contribute to internal packaging policy development.
• Demonstrate familiarity with temperature-controlled shipping container qualification, including ISTA 7D methodology and supplier engagement.
• Lead or contribute to strategic initiatives aimed at enhancing packaging capabilities and compliance.
• Mentor or manage junior packaging engineers and serve as a technical lead on cross-functional teams.
• Train new employees on SOPs, documentation systems, and packaging best practices.
• Support packaging operations by resolving deviations and investigations in collaboration with Quality and Operations.
• Initiate and manage change controls related to packaging systems and documentation.
• Travel up to 20% may be required to support external site activities and supplier collaboration.

Knowledge Requirements

• Strong technical expertise in packaging engineering and development methodologies, with experience across biologics and traditional pharmaceutical dosage forms (e.g., oral solids, powders, suspensions, small molecules, and parenterals).
• Familiarity with combination product packaging, including applicable regulatory requirements and design control principles.
• Working knowledge of FDA, cGMP, and global regulatory guidance related to container closure systems and temperature-controlled packaging.
• Proven ability to collaborate with external suppliers, contract manufacturing organizations (CMOs), and contract test laboratories.
• Strong written, verbal, and interpersonal communication skills, with the ability to clearly document and present technical work.
• Proficient in project management, organizational planning, and use of relevant software tools for documentation and analysis.
• Demonstrated ability to exercise sound engineering judgment in a fast-paced, dynamic environment.
• Experience supporting packaging activities at pharmaceutical CMOs is highly desirable.

Basic Qualifications:

• Doctorate OR
• Master’s and 4+ years of relevant experience in a cGMP-related industry OR
• Bachelor’s and 6+ years of relevant experience in a cGMP-related industry

Preferred Qualifications:

• Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field
• Proven experience in a cGMP-compliant environment, with a strong understanding of regulatory expectations for pharmaceutical and biologics packaging.
• Hands-on experience in packaging development for injectable biologics, combination products, and temperature-sensitive pharmaceuticals.
• Familiarity with TAPPI, ISTA, and ASTM standards for packaging materials and systems, including mechanical and environmental testing protocols.
• Demonstrated experience with CAD-based packaging assembly drawings, development of protective and user-friendly secondary packaging features, and implementation of moisture barrier packaging solutions for sensitive pharmaceutical and biologic products.
• Experience using electronic documentation systems such as Veeva and TrackWise for managing quality and regulatory documentation.
• Prior involvement in shipping qualification for biologic and combination products, including thermal and mechanical validation. Experience supporting technology transfer, component qualification, and design history file (DHF) development, including design inputs, verification, validation, and human factors engineering (HFE) in alignment with FDA and ISO standards.
• Active participation in professional organizations (e.g., PDA, ISPE, IoPP) or contributions to industry publications and conferences.
• Experience leading or contributing to sustainable packaging initiatives, including material selection, recyclability, and life cycle assessments (LCA).