Associate Director, Engineering (Onsite)

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Technical Operations - Engineering Lead is responsible for leading the equipment engineering team and providing technical leadership across aseptic manufacturing operations at the FLEx Sterile Rahway site. This role is a facility-facing technical leader, independent of product, and focuses on ensuring consistent and reliable production across programs on our aseptic formulation, sterile filling/lyophilization, sterile supply, and visual inspection processes. This role also owns process knowledge, oversight of process improvements, and compliance-critical technical deliverables. The leader will partner closely with Manufacturing, Quality, Development, and external partners to enable reliable supply, qualification of equipment and materials, and continuous improvement of sterile drug product processes.

Off-shift (2nd) work and overtime will intermittently be expected as a part of the role to support operations areas. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).

Key Responsibilities:

• Monitor and improve manufacturing processes, including data and reports supporting regulatory compliance of drug products as they are processed through formulation and aseptic fill/finish.
• Define and direct staff activities to plan, execute, and document experiments, studies, and manufacturing processes that qualify key equipment, raw materials, and processes for clinical and commercial production.
• Build and maintain a high-performing staff of engineers to support ongoing production and process transfers.
• Serve as a key scientific and technical representative for process-related issues at internal sites and with external partners.
• Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards.
• Perform trending and monitoring of critical attributes to maintain equipment health and control process drift.
• Identify and implement process improvements in collaboration with manufacturing operations.
• Review and provide feedback on project deliverables and offer technical/scientific support (e.g., remediation initiatives, reports).
• Lead investigations with Manufacturing, Quality, and other business units to determine root causes for variations, implement solutions, and ensure corrective actions are effective.
• Collaborate with other departments on manufacturing-related issues to resolve problems and support organizational goals.
• Own the process, plan to avoid delays, and lead activities to ensure a robust and effective product and manufacturing process.
• Perform other related duties as assigned.

Education Minimum Requirements:

• Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years relevant experience
• Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years of relevant experience, or a
• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years of relevant experience.

Required Experience and Skills:

• Excellent interpersonal and communication skills, both verbal and written.
• Expertise in drug product aseptic processing, equipment, and sterile technique.
• Experience in leading quality investigations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Lean Six Sigma Experience
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Experience with quality systems.
• Excellent organizational skills.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Experience with sterile GMP facility startup.
• Knowledge of Investigational drug regulatory requirements.
• Black Belt Certification

#PSCS

#eligibleforERP

Required Skills:
Accountability, Accountability, Business Acumen, Chemical Engineering, Chemistry, Conducting Experiments, Corrective Action Management, Cross-Functional Teamwork, Engineering Principle, Engineering Standards, Estimation and Planning, Experimental Methods, GMP Compliance, Identifying Customer Needs, Innovation, Leadership, Maintenance Supervision, Managing Engineering Teams, Manufacturing Processes, Manufacturing Scale-Up, Pharmaceutical Sciences, Production Improvement, Production Support, Regulatory Compliance, Report Writing {+ 5 more}

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
$142,400.00 - $224,100.00

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:
Domestic/International

VISA Sponsorship:
Yes

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day, 2nd - Evening

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/20/2026
*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.