What are the responsibilities and job description for the Senior Validation Specialist with CSV position at Katalyst Healthcares & Life Sciences?
Validation Strategy and Planning.
Develop and implement validation strategies specific to computerized laboratory systems and instruments (e.g., HPLC, UV-Vis spectrometers, balances).
Create and maintain validation plans, SOPs, and guidelines that address both software and hardware aspects of laboratory equipment.
Work with laboratory and IT teams to determine validation needs for new and existing instruments, software, and equipment upgrades.
Documentation and Protocol Development.
Draft and execute detailed validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Create and maintain risk assessments, impact assessments, and system traceability matrices specific to lab equipment.
Develop Data Integrity Plans to ensure data accuracy, consistency, and reliability for laboratory systems.
Validation Execution.
Lead and participate in validation testing (IQ/OQ/PQ) of laboratory equipment and software systems.
Troubleshoot and resolve issues related to laboratory equipment validation, working with vendors and internal stakeholders as needed.
Collect, review, and Analyse test data to verify system readiness and compliance with specification.
Requirements:
3-5 years of experience in computer system validation, specifically with laboratory equipment, within a regulated pharmaceutical, biotech, or medical device environment.
Familiarity with validation of lab equipment and computerized systems like LIMS, chromatography data systems (CDS), and other laboratory-specific software.
Experience with risk assessment methodologies, change control, and validation documentation for laboratory systems.
Proficiency with electronic documentation tools and systems used in validation (e.g., Veeva, Master Control, or similar).
Change Control and Periodic Reviews.
Oversee change control processes for validated laboratory equipment, including updates, upgrades, and revalidation needs.
Conduct periodic reviews and perform revalidation of lab systems according to validation lifecycle requirements.
Maintain accurate documentation and validation records for all changes and revalidation activities.
