Principal Equipment Engineer

In this role, you will provide technical leadership across a portfolio of equipment engineering initiatives that help ensure reliable, safe, and efficient manufacturing operations. You'll lead equipment lifecycle and obsolescence strategies, support the introduction of equipment into new manufacturing areas, and serve as a domain authority during investigations and sophisticated technical assessments.

Working alongside Manufacturing, Validation, Quality, Facilities, Supply Chain, and Engineering partners, you will help develop equipment solutions that enable the delivery of life-saving medicines.

When & where

• Location: Rensselaer, New York, United States
• Work model: On-Site, Monday - Friday, 08:30AM - 04:30PM

Discover your role

• Specifies cGMP process equipment, components, and spare parts
• Evaluates equipment for Functional Equivalence to existing equipment
• Assists in the design review, site acceptance and installation of equipment
• Writes and implements test plans to demonstrate equipment suitability
• Supports QA Validation department by preparation of design documents and assists in protocol execution
• Authors, reviews, and revises Standard Equipment Specifications and Engineering Design Guides and maintains library for process and utility equipment
• Implements corrective/preventative actions for existing equipment
• Prepares engineering evaluations and test plans for change control documentation
• Coordinates engineering and warehouse efforts to ensure adequate and appropriate spare parts stock
• Maintains a clean and safe working environment by carrying out procedures, policies, and regulations
• Maintains company reputation by ensuring compliance with local, state, and federal regulations
• Function as a Technical Lead for equipment/component criticality assessments and procurement of spare parts of large capital projects
• May act as SME during regulatory inspections and internal investigations
• Acts as a mentor for other Equipment Engineers sharing knowledge including but not limited to: equipment reliability, component criticality
• Assists or may lead an investigation relating to component failures
• Guide multi-functional efforts to improve asset performance, evaluate replacement solutions, and prepare manufacturing areas for future growth
• Drive equipment obsolescence initiatives by evaluating alternatives, defining specifications, and supporting implementation plans
• Partner with Manufacturing, Quality, Validation, Facilities, and Project teams to introduce equipment into production areas
• Guide design reviews, installation activities, commissioning efforts, and equipment readiness initiatives across multiple projects
• Mentor engineers and contractors while encouraging a knowledge-sharing culture within a close-knit and highly engaged team

This role requires

• BS/BA in Mechanical, Chemical, Biochemical, or related Engineering field with 8+ years of directly related experience
• Experience supporting process equipment in a regulated manufacturing environment
• Success leading technical projects, investigations, and multi-functional initiatives
• Strong understanding of equipment lifecycle management, reliability, and change control practices
• Effective communication skills with the ability to influence decisions across technical and operational teams

Preferred

• Experience with biopharmaceutical manufacturing operations
• Familiarity with validation, commissioning, or capital project activities
• Experience mentoring engineers or providing technical leadership

Gowning and Physical Requirements (if applicable)

• May require entry into manufacturing and process areas requiring appropriate gowning and personal protective equipment
• Ability to work within operational and manufacturing environments, including walking, standing, and navigating production areas as needed
• May occasionally lift or move equipment, tools, or materials according to established safety procedures