Job Title:  Lead Engineer - Validation and Qualification

Position Summary

The Lead Validation Service Engineer is responsible for meeting STERIS product serviceability, reliability, and validation requirements in cGMP-regulated markets. He or she will provide leadership, training, consultative, and technical support to STERIS and its Customers.  The Lead Validation Engineer must have sound knowledge and have demonstrated technical, quality, and scientific principles to review, execute, and deliver all aspects of our validation services.  This individual is also responsible for providing equipment service verification and high-level troubleshooting/technical support on STERIS equipment and plant MEP systems. This role will include nationwide, overnight travel up to 50%. 

Duties

Program Management (35%)

• Perform and manage a successful STERIS Equipment Validation and Service program.
• Develop validation project schedules and support all other project deliverables to meet deadlines and department standards.
• Work with the local service team and technical support to determine the right resources to resolve issues.
• Troubleshoot and analyze technical problems and clinical application issues.  Resolve immediate issues and implement changes to prevent future problems.

Quality Validation (50%)

• Review and execute Validation/Qualification protocols such as Cycle Development, Calibration, IQOQ, and PQ to meet FDA regulations and SOP requirements.  During the execution of protocols, identify and resolve any non-conformances/deviations/out-of-specification results.  According to cGMP requirements, interpret and analyze results and incorporate them into a final summary report using Good Documentation Practices (GDP).
• Interface with Regulatory and Quality Control to define and assist in implementing product upgrades, enhancements, and service procedures.

Training (15%)

• Train and manage a team of Validation Service Engineers to perform their core competencies set by the business unit.
• Provide ongoing technical and clinical product training to technical support personnel, field associates, and trainers.
• Communicate with customers and technicians in a classroom environment as required.

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Education Degree

Required Experience

1. Must have 8 years of demonstrated experience in Qualification/Validation/Servicing of process equipment used in sterilization, critical utilities, and instrument cleaning, such as Steam Sterilizers, Pure Steam Generators, and cGMP Washing equipment using cGMP, ISPE, GAMP, ASTM, or ICH guidelines.
2. Experience with the following critical utility/mechanical systems: HVAC, Electrical, Purified Water, Clean Steam, and Compressed Air (3 years)
3. Work experience in both electronic/electromechanical and computer-controlled equipment (3 years)
4. Demonstrated cGMP (GDP) documentation proficiency (1 year).

Preferred Experience:

1. Kaye Validator experience and thermal mapping of chambers and heat penetration studies of loads.
2. Understanding of appropriate handling and interpreting techniques for Biological Indicators.