GE HealthCare is looking for a Primary Packaging Scientist

The Packaging Scientist/Engineer role is part of the Lifecycle Management Team (LCM) within the Engineering and Transformation Team within the Integrated Supply Chain (ISC). The role provides technical leadership for establishing and implementing appropriate materials for primary packaging that support the Pharmaceutical Diagnostics high growth environment and product objectives. The role reports to the LCM Primary Materials Leader.

Your normal place of work will be located at a Pharmaceutical Diagnostics manufacturing site in Cork (Ireland) or Oslo (Norway).

Your main focus will be on:

• Being responsible for the primary packaging components or systems (incl. glass vials, prefilled syringes and plastic bottles, rubber stoppers and aluminium/plastic caps).
• Provide drug product packaging and container closure expertise to support R&D and Supply Chain projects in development.
• Leading lifecycle management activities of primary packaging materials for commercial products, e.g. productivity opportunities, evaluating new suppliers, implementing changes to components and technology improvements.
• Design, develop and test Container Closure Systems (CCS) for Drug Products to the required quality, safety, environmental and sustainability regulatory standards. Including design and execution of test protocols and reporting, to ensure the functionality and integrity of the chosen container closure solutions, as well as writing specifications.
• Support continuity of supply for marketed products and ensure technical performance, processability and safety of the primary packaging components and systems. (i.e., regulatory questions, support customer complaint investigations by evaluating potential root causes to ensure components and materials meet performance and quality requirements and troubleshooting manufacturing issues).
• Produce and review suitable scientific reports and documentation to support regulatory documentation packages.
• Present and defend test strategies including container closure strategy, component development files and reports to National Regulatory Authorities.
• Participate, contribute to support a best-in-class LCM community that will define, implement, and sustain global standards and processes, constantly applying LEAN mindset and methods, while fostering an LCM organization of learning and continuous improvement.
• Ability to travel globally (10 – 20 %)

Key Qualifications

• Master’s or PhD in Chemistry, Polymer Science, Pharmaceutical Sciences, Mechanical Engineering, or related field
• Significant experience in primary packaging development within the pharmaceutical industry, including experience working in a GMP environment, preferably in sterile/aseptic fill & finish or radiopharmaceuticals.
• Subject matter expertise in global packaging standards in quality, environment, health, and sustainability
• In-depth knowledge of primary materials, CCS, and relevant regulatory requirements (e.g., FDA, EMA)
• Hands-on experience with testing of CCS for root cause analysis (e.g. material/tensile testing)
• Excellent analytical and out-of-the-box problem-solving skills, with the ability to make informed decisions based on scientific data and risk assessment.
• Willingness to train, mentor, coach others.
• Interested in continuous learning and development.
• Proven ability to work collaboratively in cross-functional teams located globally, and effectively communicate complex packaging concepts to stakeholders at various levels.
• Self-motivated, highly organised, accountable, and energetic.
• Experience in lean including implementation of standard work.
• Fluent in written and spoken English

About GE Healthcare And GE HealthCare Pharmaceutical Diagnostics (PDx)

GE HealthCare is an 18B USD business with 51,000 employees working across more than 160 countries. As a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, GE HealthCare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications, and services, supported by its Edison intelligence platform and has been serving patients and providers for more than 100 years. GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient's journey across the care pathway. Together its Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring.

GE HealthCare Pharmaceutical Diagnostics (PDx) business is the global leader in imaging agents, administered to improve the images that radiologists use to diagnose and monitor disease. Its products support neurology, cardiology and oncology procedures and are used to image three patients every second.