Facilities Validation Engineer

Description

• Own and support facility validation activities in a regulated Medical Device environment.
• Participate in URS and PFMEA development
• Formulate Master Validation Plans IQ, OQ and PQ Protocols and Test Reports for new and modified facilities.
• Responsible for Facility validation Execution in conjunction with SME
• Interpret customer and contractor specifications, drawings and critical attributes for assessment during validation activities.
• Resolution of oversight and resolution of Problems encountered during facility validation including scripting of 'notes to file' and 'Validation Deviations' as appropriate
• Provide guidance and direction in the preparation and execution of facility validation activities and changes.
• Maintain facility Validation system and Register including conducting Periodic Reviews
• Participate in change control processes for manufacturing facility modifications

• Degree Educated in relevant Science or Engineering discipline
• Minimum of 4 years Quality Assurance / Regulatory affairs experience.
• Experience in working within a Medical Device Manufacturing Environment.
• Experience in HVAC, Compressor, Vacuum System or similar installations and their validation in terms of both viable and non viable particles.
• Problem solving Facility Validation challenges and issues.
• Generation and review of system level risk analysis / FMEA / Impact Assessment for facility/utility installations and upgrade.
• Sound understanding and utilization of Problem Solving Techniques
• Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
• Ability to write standard operating procedures, training documents, and regulatory responses.
• Technically Competent.
• Experience in statistical Analysis / DOE / MSA / Mathematical Modeling.
• Ability to understand and apply a risk based approach to validation of facilities/utilities and a knowledge of leveraging as per Baseline guides for facilities/utilities.