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
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