מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר
GE HealthCare Primary Packaging Scientist Ireland, Cork 719755365
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
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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