Senior Engineer, Pharmaceutical Operations Engineering

Job Description

This Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)

The FLEx sterile facility supports the formulation and filling of clinical and developmental supplies for sterile 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. Support is inclusive of both start-up operations (FLEx Sterile1) and new capital build (FLEx Sterile2).

Primary responsibility will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require routine interaction with Partner Groups such as GES (Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.

Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are maintained and are suitable for both GMP and developmental use.- Author, review and approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and approve qualification protocols and summary reports.- Execute qualifications, validation, commissioning, and decommissioning activities.- Prepare Validation plans and annual reports around critical equipment and systems.- Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment database tracking.- Facilitate and/or participate in Quality Notification (QN) reporting, investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & global engineering and maintenance groups, as well as outside vendor support.-

Provide facility engineering support and capital project administration (processing capital requests and administering capital project closeout activities) to support timely spending per approved spend plans.- Areas supported include FLEx Sterile1, with operational readiness in 4Q2025, and a secondary focus on FLEx Sterile2, currently in project phase via GES.- Provide support of the mechanical aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, supporting budgets, asset depreciation, and coordinating mechanical work performed by maintenance personnel, contractors/vendors, and facility operating staff.

Off-shift (2nd shift) work will intermittently be expected as a part of the role to support operations areas.

Education Minimum Requirement: -

• Bachelor's degree in engineering or science plus a minimum of 3 years of related Drug Product/sterile experience.
  

Required Experience and Skills :-

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
  
• Familiarity with Capital Project systems (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS).•
  
• Troubleshooting ability (mechanical/electrical/automation) and capital project (support).-
  
• Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.•
  
• Effective organizational skills.-
  
• Effective communication and technical writing skills
  
• Strong computer skills
  

Preferred Experience and Skills: -

• Maintenance & Engineering techniques and management and Capital Project management.-
  
• Track-record of independent problem-solving
  
• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)
  
• eVal / Kneat- - 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.
  

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Current Employees apply HERE

Current Contingent Workers apply HERE

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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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

U.S. 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, 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 .

You can apply for this role through (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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Adaptability, Capital Projects, Clinical Development, Detail-Oriented, Deviation Management, Equipment Qualification, Facilities Engineering, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Processes, Pharmaceutical Process Engineering, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Management System, Quality Management, Quality Management System Improvement, Reliability Management, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

-Preferred Skills:
Maintenance Engineering

Job Posting End Date:
08/9/2025
*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: R359020