Sr Engineer Finishing Equipment SME
West Pharmaceutical Services View all jobs
- Waterford
- Permanent
- Full-time
- 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.
- 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
- Ability to drive change and to think outside the box.
- Demonstrated experience managing projects in the medical device and/or pharma manufacturing industries.
- Excellent client-facing and internal communication skills.
- Strong in Project and Time Management.
- Outstanding leadership and organizational skills.
- Working experience with Microsoft office products, PowerBI, SolidWorks and/or other CAD systems.
- Able to comply with the company's safety policy at all times.
- Able to comply with the company's quality policy at all times.