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Job Description

Job Description:

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be responsible for providing automation support within our state of the facility and actively contribute to continuous improvement projects.

Job Responsibilities:

+ Provide key automation support for various manufacturing systems such as PLC, MES, SCADA, DCS, and OEM systems

+ Work with process development teams on technical development and the testing of new technologies, trialing new automation strategies, and implementing them in the GMP areas

+ Support capital projects, work to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off shift work may be required to meet project, operations, and qualification needs.

+ Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams.

+ Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems.

+ Lead integration of control systems with MES, Quality, and Batch Reporting applications.

+ Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.

+ Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentation

+ Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP

+ Lead automation related investigations into deviations and implement the corrective actions

+ Working with external companies, organizing spare parts and service visits

+ Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed

Required Education, Experience and Skills:

+ Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 4 years relevant experience, or a master’s degree with minimum years of relevant experience.

Preferred Experience and Skills:

+ At least 4 years of experience in an Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industries

+ Proven experience with development and implementation of industrial controls such as DCS (Delta V), SCADA (Wonderware, iFix), PLC applications (Siemens, Allen Bradley), , Historian (PI)

+ I/O Networking experience (i.e. Ethernet/IP, OPC, Profinet, ControlNet, Profinet, DeviceNet, and ModBus protocols) is advantageous

+ Working experience with GAMP, S88 and other industry standards.

+ Commissioning and qualification test protocol development and execution

+ Track record of working effectively with team-members of diverse skill sets and backgrounds

+ Strong presentations and verbal/written communication skills

+ Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to biologics development

+ Excellent attention to detail, highly independent with initiative

+ Excellent troubleshooting and problem-solving skills

+ Ability to challenge the status quo with a continuous improvement mindset

PRD

Required Skills:

Accountability, Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Manufacturing Compliance, Manufacturing Processes, Microbiology, New Product Development, Pharmaceutical Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation, Regulatory Compliance, Regulatory Requirements {+ 4 more}

Preferred Skills:

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

$114,700.00 - $180,500.00

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/16/2026

*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.

**Requisition ID:** R376076