• 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
• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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

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

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

No relocation