Senior Packaging Engineer

Senior Packaging Engineer

The Senior Packaging Engineer is a key member of the Engineering team and is instrumental in executing project plans directly related to packaging. This includes ownership of technical performance, compliance, validation, troubleshooting, and lifecycle management of packaging and serialization systems while serving as the primary engineering resource for packaging process development, deviation investigations, root cause analysis, and serialization compliance.

In addition, the Engineer will establish packaging systems that meet the needs of Adare's customers with optimal process and cost effectiveness. The Packaging Engineer is expected to manage projects and provide expert leadership concerning packaging and packaging systems, and collaborate with internal teams such as Quality, Technical Services, and Manufacturing, as well as with Adare's external customers in reviewing projects, providing input on packaging proposals, and recommending creative packaging solutions.

Responsibilities include:

• Evaluate, recommend, develop, implement, and maintain packaging materials, packaging systems, and serialization solutions based on operational, regulatory, quality, customer, and business requirements.
• Serve as the site technical expert for packaging and serialization systems, including packaging equipment, vision inspection systems, printers, scanners, line controllers, aggregation equipment, and enterprise serialization interfaces.
• Lead packaging development activities for new product introductions, line extensions, market launches, customer transfers, and packaging component changes.
• Collaborate with customers, Quality, Manufacturing, Technical Services, Validation, Regulatory Affairs, IT, and suppliers to develop and implement packaging and serialization solutions.
• Develop, execute, and document packaging studies, engineering trials, protocols, and technical reports to support product development, process improvements, validations, and regulatory submissions.
• Support packaging component selection, equipment selection, technology assessments, and implementation activities for packaging and serialization systems.
• Troubleshoot packaging and serialization equipment, systems, and processes to resolve technical issues, minimize operational disruptions, and maintain regulatory compliance.
• Investigate packaging and serialization deviations, non-conformances, and quality events utilizing structured root cause analysis methodologies, including 5-Why, Fishbone, Fault Tree Analysis, and CAPA development.
• Lead technical investigations related to packaging defects, vision inspection failures, barcode quality issues, aggregation failures, data transmission errors, and serialization exceptions.
• Develop, establish, monitor, and continually improve Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and control strategies associated with packaging and serialization processes.
• Conduct risk assessments, impact assessments, and Failure Mode and Effects Analysis (FMEA) activities to support process changes, equipment modifications, and new product implementations.
• Support process validation, equipment qualification, computer system validation, and serialization system lifecycle management activities, including FAT, SAT, IQ, OQ, and PQ execution.
• Participate in manufacturing feasibility studies, scale-up activities, engineering batches, validation batches, batch record development, and technical report generation.
• Maintain compliance with applicable serialization and track-and-trace regulations, including DSCSA, EU FMD, and other applicable market requirements.
• Author, review, revise, and approve SOPs, work instructions, engineering standards, validation documentation, and technical specifications supporting packaging and serialization operations.
• Collaborate with internal and external stakeholders to assess, implement, and validate packaging component, equipment, software, and serialization system changes.
• Support customer audits, regulatory inspections, supplier assessments, and due diligence activities involving packaging and serialization systems.
• Lead or participate in cross-functional project teams to execute packaging, serialization, compliance, and technology-related initiatives.
• Provide technical mentorship and guidance to manufacturing, quality, validation, technical services, and engineering personnel regarding packaging and serialization systems.
• Drive continuous improvement initiatives focused on quality, compliance, reliability, process robustness, and risk reduction within packaging and serialization operations.
• Other duties as assigned

Experience, Education, and Skills Required include:

• Bachelors' degree in Engineering or related technical field and 6+ years' experience in Packaging Engineering in a GMP industry
• Working experience with serialization systems
• Experience performing root-case analysis and deviation investigations
• Blister packaging experience is a plus
• Packaging development related to: glass, plastics, delivery systems, sterilized components
• Project management capabilities
• Lean manufacturing skills
• General knowledge of solid oral dose processing is a plus

Physical Demands and Work Environment include:

• This is primarily an on-site role based at the Philadelphia packaging facility.
• Ability to walk the production floor, climb stairs, and stand for extended periods
• Ability to wear required personal protective equipment (PPE) and follow gowning procedures when entering packaging, manufacturing, laboratory, or warehouse areas, per site requirements.
• May be exposed to manufacturing, laboratory, or warehouse environments and must follow all site safety, GMP, and gowning protocols.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

Principals Only No Agencies Or Third Parties