Associate Specialist, Engineering (Onsite)

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational start-up phase. FLEx Sterile is positioned to play a pivotal role in delivering our clinical pipeline to patients worldwide, supporting a diverse range of product modalities including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). The facility supports the formulation and filling of clinical and developmental sterile products for critical program needs, such as new products in process development, products undergoing scale-up, launch and transfer to the supply network, and existing commercial products undergoing process optimization. Support encompasses both start-up operations (FLEx Sterile1) and a new capital build (FLEx Sterile2).

The Associate Specialist, Engineering – Automation role will provide end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply (PSCS), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures the reliable and compliant operation of process automation and OT/IT systems that enable formulation, filling, lyophilization, and associated support activities for clinical and development sterile products. This position supports start-up operations and new capital investments in the clinical supply area, including automation lifecycle management, data and analytics, and site representation on capital projects. Off-shift (second shift and weekend) or extended shift work will be required on an intermittent basis to support manufacturing operations. This role will be an onsite automation support role and directly reports to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead.

Primary Responsibilities:

• Work closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support.

• Support the successful implementation of automation solutions, including both platform technologies and associated reporting needs.

• Execute / develop appropriate system validation, change control and user test acceptance documents (UAT).

• Lead/participate in installation, integration, FAT/SAT, commissioning, and qualification of new automated equipment and systems for new capital project line (FLEx sterile 2); author/execute URS/RS/CS/DS/AIOQ/UAT.

• Support a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes.

• Maintain automation systems in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current Good Manufacturing Practices. 

• Implement system changes and conduct system investigations.

• Active and engaged participation in the site tier processes (routine operations support processes) as well as supporting a culture of continuous improvement at the site.

• Troubleshoot challenging equipment/automation issues to improve equipment/automation system performance to support PSIM readiness.

• Provide support as a representative on a startup or existing production team providing technical assistance in fulfilling the automation requirements for the team. 

• Review automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with Good Manufacturing Practice and safety.

• Support and execute corrective actions for investigations related to automation/OT or IT systems.

• Develop and maintain automation and computer system validation specific standard operating procedures (SOPs).

• Perform automation system periodic reviews (PR) and system user annual reviews.

• Develop technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems. 

• Provide on-floor support of clinical manufacturing activities.

• Provide client services support for business area applications.

• Off‑shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.

 

Education Minimum Requirement: 

• BS in Engineering science, computer science, or Information system

Required Experience and Skills: 

• Knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems.

• Basic understanding of PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers.

• Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams.

• Proven root cause analysis and problem-solving skills; continuous improvement mindset.

• Strong technical writing capabilities.

• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers and vendors.

Preferred Experience and Skills: 

• Platforms/technologies: Allen-Bradley and/or Siemens PLCs; SCADA (iFix, WinCC OA, Ignition); OPC; fieldbuses (ASI/Profibus/Profinet/DeviceNet); instrumentation and panel design

• Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting

• Knowledgeable of S88 batch standards.

• Experience in biologics, vaccine or bulk sterile manufacturing facilities is plus.

• OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration

• Demonstrate a strong performance record

• Highly developed communication and teamwork skills

• Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting

• Direct impact enabling sterile product development from lab to clinic through robust, compliant automation

• Ownership across automation lifecycle, troubleshooting, and capital initiatives

• Collaboration with world-class operations, quality, engineering, IT, and security teams

#eligibleforERP

#FLEx2026

#PSCS

Required Skills:

Adaptability, Adaptability, Applied Engineering, Automated Manufacturing Systems, Biopharmaceutical Operations, CAD Proficiency, Communication, Computer Engineering, Computer Science, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, GMP Compliance, Healthcare Innovation, Interpersonal Communication, IT Demand Management, Prioritization, Process Automations, Process Optimization, Professional Engineering, Project Management, Software Proficiency, Teamwork {+ 2 more}

Preferred Skills:

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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.

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The salary range for this role is

$71,900.00 - $113,200.00

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/17/2026

*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.