Senior Packaging Engineer

About the role

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services to growing biotech firms and established pharmaceutical companies. By combining top talent with modern technologies, Adare enables clients to deliver lifesaving medicines in more easily consumable formats.

Our Culture

Across multiple countries and diverse backgrounds, we work toward a common purpose. Supported by experienced leadership, we foster a collaborative, client-centric culture where employees support one another, share knowledge, and bring their best selves to work each day.

Why Come to Adare?

Adare is Private Equity owned and poised for growth. Employees benefit from internal development opportunities across manufacturing, engineering, quality, chemistry, formulations, analytical R&D, finance, supply chain, sales, marketing, project management, HR, and environmental health and safety. Our highly competitive benefits package includes medical, dental, and vision coverage; a retirement plan with company match; paid time off and company holidays; tuition reimbursement with no waiting period; life insurance; pet insurance; Flexible Spending Accounts (medical and dependent care); and disability coverage.

Responsibilities

• 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 using 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.

Experience, Education, and Skills

• Bachelor’s 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-cause analysis and deviation investigations.
• Blister packaging experience is a plus.
• Packaging development related to glass, plastics, delivery systems, and sterilized components.
• Project management capabilities.
• Lean manufacturing skills.
• General knowledge of solid oral dose processing is a plus.

Physical Demands and Work Environment

• 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.
• May be exposed to manufacturing, laboratory, or warehouse environments and must follow all site safety, GMP, and gowning protocols.