Associate Director, Engineering

Job Description

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.

Required Experience and Skills:

• 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.

This document contains AI-generated content.

Required Skills:
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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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 ;br>
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

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

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/29/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.