Associate Director, Engineering - Packaging Technology

Job Description

This role serves as an essential part of the External Manufacturing & Network Equipment team, in providing technical leadership and support to our company's internal & external packaging network, focusing on developing and executing packaging and device assembly equipment and processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical support across the lifecycle.

The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate will possess deep process and equipment technical expertise for packaging and / or assembly, a strong track record in problem-solving, strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.

Essential Duties and Responsibilities :

The engineer will be responsible to leverage their scientific, technical, and business expertise to participate or lead in capital equipment projects, developing network equipment & process standards, solving complex packaging process and equipment issues, optimizing processes, and ensuring compliance. Effective collaboration with site-based and above-site based functional teams is crucial to achieving our company's goals. The position requires advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams.

Responsible to lead or supportcomplex technical projects and / or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part of new product introduction, product source change and / or device component source changes.

The incumbent will lead or support complex global and site-centric capital and equipment projects. These projects would include new packaging equipment purchases, packaging equipment transfer / relocation, device component source change assessment, and packaging site operational & launch support. This will include approximately 30% travel on average with occasional peaks during critical milestones.

Serving as the above-site packaging and assembly equipment SME. Individual will lead or provide direct technical support to the packaging network in areas of trouble shooting of the packaging operation, equipment and End-to-End line performance & technology analysis (i.e., continuous improvement, root cause analysis, equipment technology & capability assessments.)

The incumbent will be required to leverage packaging scientific / technical concepts and techniques (e.g., mechanical & electrical knowledge, automation expertise, AutoCAD / SolidWorks competency, equipment validation & qualification, Lean Manufacturing / Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis and etc.)) and effectively apply them in daily work to resolve scientific / technical packaging issues.

The successful candidate will be responsible for working closely with our company's Serialization CoE pertaining to our company's serialization strategy and to serve as the SME to collaborate with internal packaging sites, in North America, of its implementation, monitoring and troubleshooting support.

The qualified candidate will be accountable to establish and maintain specific packaging equipment specification standards in line with our company's Same-Same component / equipment / process principles across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector and etc.) In some cases, the individual will need to evaluate new technologies for compatibility with existing packaging lines and to collaborate closely with package sites’ technology groups to ensure alignment.

Education Minimum Requirement :

A bachelor’s degree in Packaging Science / Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.

Required Experience and Qualifications :

Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3-5 years in a leadership role ((i.e., Maintenance, Operation and / or Engineering.)

Demonstrated success in developing and implementing equipment standards across multiple manufacturing or packaging sites along with extensive practical knowledge in supporting packaging equipment design, development and qualification.

Strong background in the medical device, combination product, pharmaceutical packaging equipment and operational process and related scientific / technical concepts and techniques.

Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.

Exceptional project management skills, from conception and initiation, through project close-out.

Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification.

Expert grasp of relevant scientific or technical concepts (e.g., mechanical & electrical knowledge, automation expertise, AutoCAD / SolidWorks competency, equipment validation & qualification, Lean Manufacturing / Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis and etc.)) to handle routine and complex tasks, along with advanced practical knowledge of techniques applicable to these tasks.

Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.

Exhibited leadership qualities such as working collaboratively, managing change, accountability, adaptability and other attributes in a diverse, cross-functional team.

Proven track record inoperating in a fast-paced operating environment to resolve technical issues while meeting customer needs in a compliant manner are essential.

Demonstrated capability in operating autonomously to offer strong coordination, communication, and supervision on all technical issues.

Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.

Strong analytical and decision-making abilities, combined with outstanding oral and written communication 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 :

EEOC Know Your Rights

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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

$126,500.00 - $199,100.00

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 https : / / jobs.merck.com / us / en / compensation-and-benefits .

You can apply for this role through https : / / jobs.merck.com / us / en (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 : Domestic

VISA Sponsorship : No

Travel Requirements :

25%

Flexible Work Arrangements :

Hybrid

Shift : Not Indicated

Valid Driving License :

No

Hazardous Material(s) :

n / a

Required Skills :

Biopharmaceutical Industry, Change Management, Combination Products, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Management Process, Mechanical Engineering, Medical Devices, Packaging Engineering, Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management, Root Cause Analysis (RCA), Technical Issues, Technical Leadership, Technical Projects

Preferred Skills :

Job Posting End Date :

09 / 19 / 2025

• 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.

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