Associate Director, Engineering

Merck•Upper Gwynedd Township, PA

2d•Hybrid

About The Position

At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. We are seeking a passionate and experienced Associate Director of Engineering to join our team. This role offers a unique opportunity to contribute to the development of cutting-edge biologic and vaccine drug substances, drug products, and medical device combination products. If you are driven by the power of leading-edge science and want to make a meaningful impact on global health, we invite you to apply. Responsibilities: Provide technical expertise from initial design concept through product launch with a primary focus on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs). Influence oral solid dosage form packaging design as needed based on complexity. Understand considerations of complex packaging design and the interplay between product and package. Identify and mitigate risks through structural and materials design optimization. Collaborate with other engineers to influence the data-driven development of packaging systems for sterile and non-sterile products. Upskill fellow packaging engineers on risk-based experimental design and data analysis. Build inclusive, collaborative partnerships with internal and external stakeholders. Display ownership and proactively identify opportunities to build technical rigor into standard work and packaging platforms. Drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups. Navigate complex situations in a fast-paced environment while aligning packaging with product and patient needs. Education Requirements: 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Provide technical expertise from initial design concept through product launch with a primary focus on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs).
Influence oral solid dosage form packaging design as needed based on complexity.
Understand considerations of complex packaging design and the interplay between product and package.
Identify and mitigate risks through structural and materials design optimization.
Collaborate with other engineers to influence the data-driven development of packaging systems for sterile and non-sterile products.
Upskill fellow packaging engineers on risk-based experimental design and data analysis.
Build inclusive, collaborative partnerships with internal and external stakeholders.
Display ownership and proactively identify opportunities to build technical rigor into standard work and packaging platforms.
Drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups.
Navigate complex situations in a fast-paced environment while aligning packaging with product and patient needs.