Job Description
The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge drug product cGMP clinical supply manufacturing facility, known as FLEx Non-Sterile. The FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.
The Specialist, Automation Engineering supports clinical manufacturing automation systems at the Rahway FLEx Center in Rahway, NJ, with a focus on non-sterile manufacturing operations. This role provides hands-on support for validated automation and OT/IT systems used in clinical and development manufacturing, including troubleshooting, system maintenance, change control, and documentation. The position works closely with Manufacturing, Quality, IT, and engineering partners to help ensure reliable, compliant operation of automation systems in a GMP environment.
This is an onsite role that may require occasional off-shift or weekend support based on manufacturing needs.
Primary Responsibilities
- Support automation systems used in clinical manufacturing by maintaining them in a validated, compliant state in accordance with cGMP, safety, data integrity, and cybersecurity requirements.
- Provide on-floor and technical support for manufacturing operations, including troubleshooting automation, controls, instrumentation, electrical, and software issues.
- Assist with root cause analysis, investigations, CAPAs, and corrective actions related to automation and OT/IT systems.
- Support system changes through change control, including documentation, impact assessments, implementation support, and testing.
- Assist with commissioning, qualification, and validation activities for new or modified automation systems and equipment.
- Maintain accurate and inspection-ready documentation, including SOPs, equipment records, drawings, configurations, and maintenance/support documents.
- Support automation-related reporting, trending, and basic visualization tools using historian or SCADA data to help monitor system performance and reliability.
- Work with divisional and enterprise IT, infrastructure, Quality, Manufacturing, and external vendors to support automation system reliability and compliance.
- Participate in audits, inspections, and site support activities as needed.
- Support automation lifecycle activities such as periodic reviews, backups, patching, user access administration, and obsolescence remediation under direction.
- Contribute to continuous improvement efforts focused on system stability, reliability, and supportability.
- Provide support for capital projects as a site automation representative, with limited scope focused on implementation support, testing, and system readiness.
Education Requirement
- Bachelor’s degree in Engineering, Science, Information Technology, or a related field
- Minimum of 2 years of experience in process automation or a related technical area
Required Experience and Skills
- Strong understanding of cGMP, quality systems, safety, data integrity, and validation principles for automation and computer systems
- Hands-on experience supporting validated automation systems in a regulated environment
- Experience with change control, troubleshooting, investigations, and documentation support
- Working knowledge of PLC/SCADA systems and industrial networking fundamentals
- Ability to troubleshoot across controls, instrumentation, electrical, software, and OT/IT layers
- Strong interpersonal, communication, and technical writing skills
- Demonstrated problem-solving skills and a continuous improvement mindset
- Ability to work collaboratively across functions and support multiple priorities in a fast-paced environment
Preferred Experience and Skills
- Experience with Allen-Bradley and/or Siemens PLCs
- Experience with SCADA platforms such as iFix, WinCC OA, or Ignition
- Familiarity with industrial communication protocols such as OPC, Ethernet/IP, PROFINET, Profibus, DeviceNet, or AS-i
- Exposure to automation reporting, historians, databases, or basic scripting
- Experience in pharmaceutical manufacturing or other regulated manufacturing environments
- Experience supporting qualification or validation documentation
- Exposure to electronic quality or validation systems
- Experience supporting audits, SOPs, or controlled documentation
#eligibleforERP
FLEx2026
#PSCS
**Required Skills: **
Adaptability, Adaptability, Analytical Instrumentation, Automation Engineering, Automation Systems, Bioprocessing, Capital Projects, cGMP Compliance, Change Control Processes, Computerized Maintenance Management Systems (CMMS), Continuous Process Improvement, Data Analysis, Detail-Oriented, Electrical Systems, GMP Compliance, Information Communication Technology (ICT), Job Descriptions, Maintenance Supervision, Mechanical Systems, New Product Development, Pharmaceutical Manufacturing, Process Automations, Process Control, Production Operations, Regulatory Compliance {+ 2 more}
**Preferred Skills: **
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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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
$87,300.00 - $137,400.00
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:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day, 2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/26/2026
***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. **