he Global Quality Staff Validation Engineer is responsible for supporting validation needs of the Life Science Solutions Group. The Staff Engineer will provide guidance and improve validation activities across the Life Science Solutions Group.
What will you do?
- Prepare, revise and/or execute validation master plans, commissioning documents, validation protocols, reports and annual reviews for equipment, systems, and processes for LSG sites globally for compliance with FDA and ISO guidelines.
- Assist sites globally for validation program remediations by creating gap assessment, plans, master planning, and template creations
- Prepare sites for quality and regulatory audits by implementing and improving quality management systems
- Participate in inspections, audits, and audit readiness
- Stay current on worldwide requirements, including identifying gaps and implementing program changes and improvements to remain in compliance
- Interact with site personnel as a validation SME to ensure validation activities are planned and completed according to requirements
- Provide training and mentoring to sites on validation concepts
- Develop training content for onsite and virtual training sessions
- Ensure policies, procedures and practices are in compliance with global quality & regulatory requirements and meets the needs of our customers
- Summarize and evaluate protocol data, including resolution of discrepancies and exceptions as required for completion of validation summary reports.
- Perform periodic reviews or re-qualifications to maintain validation status of equipment, instruments, facilities, utilities, and computer systems as defined by approved validation SOPs.
- Participate on the Thermo Fisher Scientific Validation Council
How will you get there?
- B.S. Degree in Engineering or scientific discipline
- 5+ years validation experience in the pharmaceutical or medical device industry performing the tasks listed above.
- Influence and coordinate activities of personnel over which he/she has no direct authority
- Work independently with minimal supervision
- Thorough knowledge of process, equipment and software validation principles and concepts
- Proficient on validation and qualification protocol development, data analysis and report writing
- Proficient in statistical analysis and process control
- Experience with change management assessments for validated equipment, systems, and processes.
- Demonstrated ability to work on multiple projects effectively.
- Independent self-starter who is capable of planning schedules, control plans and leading projects as assigned.