Key Role: Process Validation Specialist
Job Description:
We seek an experienced engineer with advanced expertise in metrology and validation to support NPI projects and facility expansions.
1. Create comprehensive validation protocols for equipment, processes, and products ensuring compliance with industry standards such as ISO 13485 and FDA.
2. Develop and lead validation activities for new product launches, process changes, and facility expansions collaborating with cross-functional teams including engineering, quality, manufacturing, regulatory.
3. Serve as a technical expert in metrology and validation during NPI project phases supporting prototype builds pilot runs full-scale production launches participate in risk assessments FMEA process mapping control plan development for new products ensure facility readiness by coordinating equipment qualification process validation documentation with relevant stakeholders maintain accurate thorough documentation aligned with regulatory quality company standards prepare validation reports inspection records change control documentation for audits regulatory submissions support internal external audits responding audit observations implementing corrective actions identify lead process improvement initiatives related metrology validation NPI activities provide training mentorship junior engineers technicians metrology validation best practices stay current emerging technologies regulatory changes industry trends enhance department capabilities qualifictions&experience Bachelors Masters degree Engineering Mechanical Biomedical related discipline proven experience metrology techniques tools CMM gauges calibration hands-on experience IQ/OQ/PQ regulated environment medical device pharma similar strong problem-solving analytical communication skills experience quality management systems ISO 13485 FDA regulatory audits ability work collaboratively cross-functional teams manage multiple projects simultaneously experience risk management FMEA process mapping statistical analysis flexibility adaptability dynamic project requirements timelines