Sterile Specialist, Engineering (Onsite)

Merck•Rahway, NJ

2d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

Maintain facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements
Apply Reliability Maintenance best practices to ensure timely availability of clinical and development batches
Equipment troubleshooting
Routine interaction with Partner Groups such as GES (Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors
Provide support for Quality Engineering (QE) and capital project
Support the full equipment validation lifecycle (from commissioning through decommissioning) by preparing, executing, and approving protocols
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
Support the sterile validation program, both sterilization and cleaning
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