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MSD Malaysia

Associate Director, Engineering

MSD Malaysia, Phila, Pennsylvania, United States

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* Bachelors degree (B.S./B.A) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; OR* Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience; OR* PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience.* Large molecule autoinjector design experience* End-to-End experience in packaging of pharmaceutical and/or medical device/combination products.* Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.* Experience with a variety of primary, secondary, and tertiary packaging types common in the biopharmaceutical industry.* Use of design and modeling tools to enhance understanding of distribution stresses and packaging dynamics.* Ability to determine interrogate the science, identify true requirements, and proactively detect critical flaws.* Leadership skills to enable collaboration with diverse business partners.* Ability to drive complex projects to completion in a fast-paced environment.* Ability to navigate ambiguity, embrace experimentation and learning, and model a growth mindset.* Ability to identify technical capability gaps and influence other engineers.* Excellent technical written and oral communication skills.* Proficient in problem solving, risk-based decision-making, and use of standard work.* Ability to maintain subject matter expertise and help the organization grow and learn in packaging development.**Preferred** **Experience and Skills:*** Background in application of numerical design and modeling tools.* Quality by Design (QbD) experience.* Experience in defining standard work processes and documents.* Experience specifying, processing, and characterizing packaging materials.* Expertise in hypothesis development and testing, statistical analysis, and Design of Experiments.* Lean Six Sigma or Design for Six Sigma certification.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr