Associate Director, Engineering

Responsibilities:
- Provide technical expertise from initial design concept through product launch, focusing on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs).
- Influence oral solid dosage form packaging design based on complexity.
- Understand complex packaging design considerations and the interplay between product and package.
- Identify and mitigate risks through structural and materials design optimization.
- Collaborate with other engineers to influence 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.
- Demonstrate ownership; proactively identify opportunities to build technical rigor into standard work and packaging platforms.
- Drive the right risk posture balancing technical probability, cost/resources, and trade-offs across groups.
- Navigate complex situations in a fast-paced environment while aligning packaging with product and patient needs.

Education Requirements:
- Bachelor’s degree (B.S./B.A.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar with 10 years of relevant pharmaceutical development experience; OR
- Master of Science (M.S.) with 8 years of relevant pharmaceutical development experience; OR
- PhD with 5 years of relevant pharmaceutical development experience.

Required Experience and Skills:
- Large molecule autoinjector design experience.
- End-to-end packaging experience for pharmaceutical and/or medical device/combination products.
- Knowledge of US and global regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.
- Experience with primary, secondary, and tertiary packaging types common in biopharma.
- Use of design and modeling tools to understand distribution stresses and packaging dynamics.
- Ability to interrogate science, identify true requirements, and proactively detect critical flaws.
- Leadership skills for collaboration with diverse partners.
- Ability to drive complex projects to completion in a fast-paced environment.
- Ability to navigate ambiguity; embrace experimentation and learning; 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 applying numerical design and modeling tools.
- Quality by Design (QbD) experience.
- Experience defining standard work processes and documents.
- Experience specifying, processing, and characterizing packaging materials.
- Expertise in hypothesis development/testing, statistical analysis, and Design of Experiments.
- Lean Six Sigma or Design for Six Sigma certification.

Required Skills (from posting): Biologics, Combination Products, Compliance Packaging, Engineering Standards, Good Manufacturing Practices (GMP), Injection Devices, Leadership, Manufacturing Scale-Up, Packaging Engineering, Process Optimization, Root Cause Analysis (RCA), Technical Leadership.

Application instructions:
- Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee).