MSD
Overview
This Engineer position will provide engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for non-sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci) and Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The FLEx facility supports formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including programs related to process development, scale-up, launch and transfer to the supply network, and optimization of existing commercial products. Responsibilities
Maintain equipment in accordance with GMP and safety requirements, and apply Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet program requirements. Work with Partner Groups (Facilities Management, OEM) and interface with the OSD Business area to ensure manufacturing activities are not delayed. Provide engineering and quality engineering (QE) support to ensure facilities, utilities and equipment are suitable for GMP and developmental use. Author, review, and update GMP procedures and documentation, focusing on Qualification/Validation plans and annual reports for equipment, critical utilities, and computer systems. Demonstrate equipment operation knowledge to support troubleshooting, drive improvements, and contribute to protocol development. Prepare and execute qualifications, commissioning, and decommissioning activities. Maintain GMP documentation such as engineering drawings and equipment database tracking. Facilitate and/or participate in Quality Notifications (QN), investigations and CAPA activities. Support internal audits and regulatory inspections with timely responses. Facilitate equipment/system changes, perform periodic reviews, and support Quality Management System (QMS) activities. Provide capital project support for small and large multi-disciplinary projects; interface with site engineering, maintenance groups and outside vendors; support ongoing operations and installation of capital/facility improvements. The FLEx Center operates on a two-shift schedule and requires coverage beyond standard business hours. Education Minimum Requirement
Bachelor's Degree in Engineering or Science plus a minimum of 3 years of related Drug Product/OSD experience. Required Experience and Skills
Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures. Familiarity with Root Cause Analysis and investigations. Troubleshooting ability (mechanical/electrical/automation) and capital project support. Ability to adapt to the flow of work across both Quality and Facility aspects to support the business. Effective organizational skills. Effective communication. Strong computer skills. Preferred Experience and Skills
Engineering, maintenance & calibration experience of pharmaceutical processing equipment and utility systems. SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance. eVal - Paperless electronic validation system. Experience with ProCal as a Computerized Calibration Maintenance System (CCMS). Familiarity with Planning and Scheduling practices as well as business/financial practices. The candidate should be able to work independently and lead or facilitate tasks successfully. EEO and Other
US and Puerto Rico Residents Only: Our company is committed to inclusion and providing equal opportunities in hiring. Please contact us 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 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 legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA supplements pages. We are a company that values diversity and inclusive collaboration, and we encourage candidates with diverse experiences to apply. Salary and Benefits
The salary range for this role is $85,600.00 - $134,800.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement (401(k)) and paid holidays, vacation, compassionate and sick days. More information about benefits is available at the company benefits page. Application and Posting Details
You can apply for this role through the company’s careers site. The application deadline is shown on the posting. Additional Information
Job Posting End Date: 12/31/2025. See the posting for any other requirements or notes.
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This Engineer position will provide engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for non-sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci) and Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The FLEx facility supports formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including programs related to process development, scale-up, launch and transfer to the supply network, and optimization of existing commercial products. Responsibilities
Maintain equipment in accordance with GMP and safety requirements, and apply Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet program requirements. Work with Partner Groups (Facilities Management, OEM) and interface with the OSD Business area to ensure manufacturing activities are not delayed. Provide engineering and quality engineering (QE) support to ensure facilities, utilities and equipment are suitable for GMP and developmental use. Author, review, and update GMP procedures and documentation, focusing on Qualification/Validation plans and annual reports for equipment, critical utilities, and computer systems. Demonstrate equipment operation knowledge to support troubleshooting, drive improvements, and contribute to protocol development. Prepare and execute qualifications, commissioning, and decommissioning activities. Maintain GMP documentation such as engineering drawings and equipment database tracking. Facilitate and/or participate in Quality Notifications (QN), investigations and CAPA activities. Support internal audits and regulatory inspections with timely responses. Facilitate equipment/system changes, perform periodic reviews, and support Quality Management System (QMS) activities. Provide capital project support for small and large multi-disciplinary projects; interface with site engineering, maintenance groups and outside vendors; support ongoing operations and installation of capital/facility improvements. The FLEx Center operates on a two-shift schedule and requires coverage beyond standard business hours. Education Minimum Requirement
Bachelor's Degree in Engineering or Science plus a minimum of 3 years of related Drug Product/OSD experience. Required Experience and Skills
Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures. Familiarity with Root Cause Analysis and investigations. Troubleshooting ability (mechanical/electrical/automation) and capital project support. Ability to adapt to the flow of work across both Quality and Facility aspects to support the business. Effective organizational skills. Effective communication. Strong computer skills. Preferred Experience and Skills
Engineering, maintenance & calibration experience of pharmaceutical processing equipment and utility systems. SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance. eVal - Paperless electronic validation system. Experience with ProCal as a Computerized Calibration Maintenance System (CCMS). Familiarity with Planning and Scheduling practices as well as business/financial practices. The candidate should be able to work independently and lead or facilitate tasks successfully. EEO and Other
US and Puerto Rico Residents Only: Our company is committed to inclusion and providing equal opportunities in hiring. Please contact us 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 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 legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA supplements pages. We are a company that values diversity and inclusive collaboration, and we encourage candidates with diverse experiences to apply. Salary and Benefits
The salary range for this role is $85,600.00 - $134,800.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement (401(k)) and paid holidays, vacation, compassionate and sick days. More information about benefits is available at the company benefits page. Application and Posting Details
You can apply for this role through the company’s careers site. The application deadline is shown on the posting. Additional Information
Job Posting End Date: 12/31/2025. See the posting for any other requirements or notes.
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