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Senior Validation Expert
2 weeks ago
Job Title: Senior Validation Professional
About the RoleWe are seeking a highly skilled and experienced validation professional to join our team. As a senior validation professional, you will be responsible for leading the qualification and validation of computer systems, equipment, and analytical instruments in the Life Sciences industry.
Your key responsibilities will include:
- Planning, performance, and coordination of computer system validation, equipment qualification, temperature-controlled objects (freezers, incubators, etc.), clean utilities validation, and cleaning validation in accordance with internal procedures and industry standards.
- The qualification includes FAT, SAT, IQ, OQ, PQ of any additional modifications of existing manufacturing process equipment, package units (e.g., Ultrafiltration Unit, Chromatography Columns, Autoclave, FIT testers), commercial off-the-shelf (COTS) analytical instruments, freezers, etc.
- Create, review, and approve equipment qualification and analytical instruments lifecycle documentations, e.g., FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Lead investigation revolving around discrepancies identified during qualification activities.
To be successful in this role, you will need to have:
- Relevant experience in validation activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents).
- Leading daily validation meetings with cross-functional teams in resolving validation issues.
- Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
- Work experience in Pharmaceutical or BioPharma industries.
- Hands-on validation execution experience.
- Able to execute activities in cGMP environment, including cleanrooms or technical areas.
We are looking for candidates who possess the following skills and qualifications:
- Quality Management
- Quality Assurance
- Quality System
- Ultrafiltration
- Chromatography
- Investigation
- Temperature-Controlled
- Cleaning Validation
- Computer System Validation
- Equipment Qualification
- Team Player
- Instrumentation
- Life Sciences
- Project Delivery
- Manufacturing
- Commissioning
- Analytical Instruments
- Autoclave
