The Senior Packaging Engineer is responsible for management of packaging projects including but not limited to the creation of engineering documents (drawings, specifications, protocols, reports, change controls, etc), execution of packaging test plans, execution of shipping validation studies, development of labeling and artwork solution, and management of external packaging vendors and internal stakeholders to support the production of personalized cell therapy products for both global clinical trials and commercial supply. Candidate is expected work on cross functional teams, exhibit ownership and deliver on-time results while optimizing quality and performance. This is a unique opportunity to work on packaging of novel cell therapy products within Global Manufacturing Science and Technology Organization.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Demonstrated skills in project management with the ability to independently plan, prioritize, schedule and coordinate multiple projects simultaneously
- Excellent analytical, critical-thinking, and creative problem-solving skills, with ability to analyze information / situations efficiently. Strong skills in technical writing.
- Attention to details with focus on quality.
- Flexible in adapting to changing project priorities and work assignments.
- Ability to work under pressure with demanding deadlines, and Manage risk and make rapid decisions
- Drive strong collaboration within the plant and across the network and Promote a mindset of continuous improvement, problem solving, and prevention
- Experience in a cGMP environment with track record of managing multiple quality records.
- Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals including primary container analysis.
- Thorough understanding of regulations, familiarity of regulatory environment and industry trends for design of primary/secondary container, labeling.
DUTIES AND RESPONSIBILITIES
- Lead on development of packaging and shipping validation test plans, generating test protocols, executing testing internally and with external test labs, and generating test reports.
- Collaborates with development team to ensure all novel primary and secondary packaging materials including labeling components meet technical, legal, and regulatory requirements.
- Liaisons with manufacturing and operational sites to support packaging and shipping related deviation investigations/Corrective and Preventative Actions (CAPAs), impact assessments, and change controls.
- Creates and maintains packaging specifications and artworks for primary packaging, secondary packaging, and shipping materials and components.
- Stays current with industry/regulatory standards and trends, drives continuous-improvement and optimization projects within the packaging engineering and larger GMSAT teams.
- Involvement (Either leading or supporting) with all activities related to the functional packaging, labeling, and shipping requirements for the incoming raw materials and final drug product.
- Leads activities to determine requirements for packaging/labeling/shipping materials, obtains prototypes, drafts protocols and reports for feasibility, qualification, and validation, to ensure packaging/labeling materials and systems appropriately protect the product and patient including: stability, distribution qualifications, package strength/integrity, biocompatibility, leachables/extractables, label adherence/legibility, etc.
- Preparation of Packaging documentation for Regulatory submissions and maintain permanent inspection readiness and actively support regulatory inspections.
- Providing guidance to the manufacturing/packaging process, and product clinical and commercial labeling activities at the manufacturing site.
- Initiates and performs packaging studies to contain package material cost or effect package changes that result in greater efficiency, less waste, longer stability, etc. Expresses desire to make high quality decisions based on sound analysis and review of data and alternatives.
- Oversee technical challenges for material, label & packaging selection. Identify ‘best practices’ for label printing.
EDUCATION AND EXPERIENCE
- Bachelor’s Degree in Engineering required (Packaging Science or Package Engineering is preferred)
- 8 or more years of Package Engineering experience in a healthcare related industry (Biologics, Medical Device, Pharmaceutical preferred)
- Experience working with cold-chain shipper Design/Qualification required (LN2/cryogenic technologies preferred) ASTM and ISTA packaging test standards and methods.
- Experience working with external packaging, test lab vendors and leading cross-functional teams is required.
- Experience with AutoCAD/ArtiosCAD, Adobe Illustrator and Photoshop.
- Experience with current Good Manufacturing Practices (cGMP’s), cGDP’s, and Data Integrity.
- Experience with Label and artwork design, Thermal Transfer Printers, Labeling Software/Systems, Label Testing, COI/COC preferred
- Strong verbal/written communication skills and ability to influence at all levels is required
- Ability to think strategically and to translate strategy into actions
- Ability to prioritize and provide clear direction to team members in a highly dynamic environment