Facilities Engineer

Facilities Engineer – Sterile/Aseptic Manufacturing
(Branchburg, New Jersey)   

Our client is seeking a hands-on Facilities Engineer to support the reliable operation and ongoing improvement of a growing sterile injectable manufacturing facility in Branchburg, New Jersey. This position is a Direct Hire. Role focuses on the operation, maintenance, and optimization of existing facility systems that support aseptic manufacturing. The engineer will establish maintenance requirements, identify opportunities to improve system performance, and assess risks that could affect facility operations, product quality, or production continuity.

Candidates must have demonstrated U.S.-based pharmaceutical manufacturing experience and a working understanding of U.S. cGMP expectations. Experience in sterile or aseptic manufacturing is required. This is not an end-to-end capital project or greenfield construction role.

Key Responsibilities:
Own the reliable operation and lifecycle performance of facility systems, related examples include: Steam boilers, Process chiller systems, 12 air handling systems, Domestic hot water systems, Electrical systems, Waste neutralization systems, etc..
Define and maintain preventive and corrective maintenance requirements for assigned systems.
Identify, assess, and prioritize system risks and vulnerabilities that could affect facility operations, safety, compliance, or production continuity.
Recommend and implement practical improvements to optimize system reliability, performance, and efficiency.
Troubleshoot equipment and system issues, determine root causes, and coordinate timely resolution.
Work with Maintenance, Operations, Quality, Validation, and EHS to support compliant, safe, and reliable facility operation.
Maintain accurate technical documentation, maintenance records, procedures, and system information.
Support inspections, audits, and investigations related to facility systems.
Coordinate with contractors and service providers as needed to maintain and improve assigned systems.

Qualifications and Experience:
Bachelor’s degree in Mechanical Engineering preferred; Electrical or Industrial Engineering will also be considered.
Demonstrated experience in U.S.-based pharmaceutical manufacturing.
Required experience in sterile or aseptic manufacturing environments.
Experience supporting facility systems in a regulated manufacturing setting, including maintenance, troubleshooting, and continuous improvement.
Working knowledge of U.S. FDA cGMP requirements and applicable safety standards.
Strong problem-solving skills and the ability to identify operational risks and recommend effective solutions.
Effective communication skills and the ability to work across technical and non-technical teams.

Company & Site Overview:
At the Branchburg, New Jersey manufacturing facility, mission is to establish a state-of-the-art pharmaceutical manufacturing plant dedicated to producing high-quality, sterile injectable IV bag specialty products, with an unwavering commitment to patient safety and care. As a patient-oriented and rapidly growing organization, focus is on delivering specialty, value-added sterile injectables that bridge critical gaps in the market by supporting healthcare workers through improved hospital workflows, reduced waste of key resources, and increased operational efficiencies. This facility marks the foundation of our broader vision to become a trusted leader in sterile manufacturing, with plans to swiftly expand our innovative product portfolio to address evolving healthcare needs.

Quality Engineering Technician (CMM) Horseheads, NY
Our client located in Horseheads, NY, is currently hiring a Quality Assurance Technician to develop,  validate and maintain CMM and automated inspection programs which will support first article, in-process, and final inspection activities; strong emphasis skills on CMM and/or automated vision inspection system operation, programming, and data-driven analysis preferred.

This role is a fully benefited Contract to hire role- offering a full benefits package and significant opportunities for company growth in a supportive team environment.

KEY RESPONSIBILITIES:
Perform inspection and testing of components using manual gaging and automated systems, including CMMs and vision systems (e.g., Keyence), with strong emphasis on method development.
Develop, validate and maintains CMM and automated inspection programs to support First Article, in-process, and final inspection activities.
Conduct First Article Inspection (FAI/FIR), incoming, in-process, and final inspections in accordance with drawings, specifications, and quality plans.
Perform complex measurement, analysis, and documentation to ensure products meet established specifications and quality requirements.
Support New Product Introduction (NPI) and design transfer activities through inspection planning, automated inspection method development, and validation.
Support and conduct Gage R&R/Test Method Validation and other measurement system capability assessments across manual and automated inspection platforms.
Participates in root cause analysis and formulates corrective and preventive action recommendations.

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