MSD
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&I‑Ds, 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.
EEO Statement 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.
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, while Friday is 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.
Salary and Benefits The salary range for this role is $114,700.00 – $180,500.00.
The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including a 401(k), paid holidays, vacation, and compassionate and sick days.
Application To apply for this role, please visit our careers site. The application deadline for this position is stated on this posting.
Legal Information We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Other Information 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 11:59:59 PM 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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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&I‑Ds, 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.
EEO Statement 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.
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, while Friday is 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.
Salary and Benefits The salary range for this role is $114,700.00 – $180,500.00.
The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including a 401(k), paid holidays, vacation, and compassionate and sick days.
Application To apply for this role, please visit our careers site. The application deadline for this position is stated on this posting.
Legal Information We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Other Information 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 11:59:59 PM 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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