About the role

  • Sr Engineer SME for pharmaceutical washing and sterilization equipment in a dedicated healthcare company. Collaborating globally to improve production equipment and processes across manufacturing sites.

Responsibilities

  • Serve as the global Subject Matter Expert (SME) for pharmaceutical washing and sterilization equipment
  • Lead engineering, management, plant operations, and global team members while collaborating with vendors to develop specifications for new equipment and improvements to existing systems supporting rubber mixing and dimensioning processes
  • Drive the standardization and harmonization of production equipment and related documentation across the global network
  • Partner with Process Engineering to analyze and evaluate existing systems and processes, identifying value-added and non-value-added activities to define design challenges and improvement opportunities
  • Stay informed on emerging equipment standards and market trends, proactively identifying value-added improvements that enhance performance and efficiency
  • Work independently and with vendors to investigate root causes of equipment failures, propose design or component changes, and implement and validate modifications
  • Lead systematic problem-solving activities to support manufacturing plants in resolving equipment-related issues
  • Coordinate and/or execute all necessary GMP-related validations and process engineering evaluations for manufacturing equipment
  • Act as the primary technical point of contact for equipment vendors and suppliers, ensuring clear communication of tasks and monitoring deliverables, including FAT, SAT, IOQ, and related activities
  • Establish equipment standards based on industry best practices to achieve corporate goals for Quality, Efficiency, Cost Reduction, and Safety
  • Manage equipment projects from URS development through PQ, applying current project management practices and ensuring GMP-compliant documentation
  • Research and analyze vendor proposals, specifications, and manuals to assess feasibility and application suitability
  • Collaborate with cross-functional teams to align equipment initiatives with corporate objectives
  • Ensure all equipment complies with the latest Safety Regulations and internal standards

Requirements

  • Bachelor’s or Master’s degree in Science or Engineering (Electrical, Mechanical, or Industrial preferred)
  • Minimum of 5 years of experience in a pharmaceutical manufacturing environment
  • Strong understanding of engineering principles in cleanroom and GMP environments
  • Proven experience managing equipment projects, including specification, procurement, installation, and qualification
  • Excellent engineering and troubleshooting skills
  • Demonstrated experience in project management, including the ability to manage projects in a dynamic environment with minimal supervision
  • Working experience with Microsoft office products, PowerBI, SolidWorks and/or other CAD systems

Benefits

  • Health insurance
  • Professional development opportunities
  • Paid time off
  • Commitment to creating a healthier environment and planet through sustainability efforts

Job title

Senior Engineer – Finishing Equipment SME

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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