Sterile Specialist, Engineering (Onsite)

Job Description

This Engineer position will provide on-site engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, for sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift) work is required to meet the operational needs.

The FLEx facility supports the formulation and filling of clinical, stability, 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. Areas supported include FLEx Sterile1, with operational readiness in 4Q2025, and a secondary focus on FLEx Sterile2, currently in capital project phase. Pharm Ops Engineering serves to provide support for quality engineering, equipment reliability and maintenance, and sterilization and cleaning validation.

The primary responsibility of this role is to maintain facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements, while applying Reliability Maintenance best practices to ensure timely availability of clinical and development batches. This will require equipment troubleshooting and routine interaction with Partner Groups such as GES (Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.

The individual is to provide support for Quality Engineering (QE) and capital project. This includes interfacing with site engineering and maintenance groups, as well as external vendors, to support ongoing operations, upgrades, and installation of new capital equipment. The role will support the full equipment validation lifecycle (from commissioning through decommissioning) by preparing, executing, and approving protocols. Responsibilities also include managing equipment/system changes, performing periodic reviews. Evaluate deviations, issue Quality Notification (QN), perform investigations, identify root causes and any related corrective actions/ preventive actions (CAPA). Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment database tracking. Support the mechanical aspects of clinical operations. Coordinate activities executed by maintenance personnel, and contractors/ vendors. Support gatekeeping of work orders. Manage purchase orders, supporting budgets and asset depreciation. Support capital project administration, including processing capital requests and managing project close-out activities. Coordinate installation, upgrades, and commissioning of new capital equipment. Support regulatory interactions as a Subject Matter Expert (SME) when needed.

Additional responsibility will be to support the sterile validation program, both sterilization and cleaning. The program will leverage third-party support (vendor) for execution activities and consultation on program details and requirements. Individual will function as Subject Matter Expert (SME) on validation of equipment used for sterilization and cleaning in clinical drug product manufacturing. Own, author and/or review validation SOPs, protocols, and summary reports. Perform technical assessments for new parts or soil matrix. Help coordinate field execution and align necessary equipment and instruments. Address any issues or challenges from conceptual to approval.

Education Minimum Requirement:

• Bachelor's degree in engineering or science plus a minimum of 2 years of related Drug Product/Sterile/Validation experience.

Required Experience and Skills:

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Sterile Drug Product manufacturing equipment and process.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Troubleshooting ability (mechanical/electrical/automation)
• 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.
• Independent problem- solving.
• 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.

#eligibleforERP

#PSCS

Required Skills:
Accountability, Accountability, Adaptability, Biopharmaceuticals, Biopharmaceutics, Capital Projects, cGMP Guidelines, Electronic Batch Records, Emergency Care, Equipment Maintenance, Ethylene Oxide Sterilizers, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Orthopedics, Periodic Reviews, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Purchase Orders, Quality Engineering, Reliability Management, SAP Plant Maintenance (PM) {+ 5 more}

Preferred Skills:

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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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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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
$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 ;br>
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:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day, 2nd - Evening

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/23/2026
*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.