Katalyst Healthcares and Life Sciences
Job Description:
We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentation from the vendors, evaluate what information is needed and create user requirements and all associated documentation. This is a highly accelerated project that needs to be completed in a 6-8-week timeline. The candidate must have at least 5 years of experience withing Building Management and Environmental Monitoring systems and can individually create and execute the appropriate documentation.
Responsibilities:
Draft and execute URS for computerized facilities, utilities, and equipment systems. Perform and document risk assessments and ERES (Electronic Records and Electronic Signatures) assessments. Develop and execute validation deliverables: FS/DS, IQ, OQ, PQ protocols, and traceability matrices. Validate EMS/Client systems for environmental monitoring and building controls. Validate laboratory software platforms, including HPLC/qPCR data systems, SciNotes, and Blue Mountain (plus). Verify compliance with data integrity principles (ALCOA+), Part 11, and Annex 11 requirements. Document results, deviations, and resolution activities. Deliver complete GMP-ready CSV reports for QA review and approval. Collaborate with CQV Engineers, Technical Writers, and QA to ensure consistency across FEU, LEQ, and CSV validation workstreams. Requirements:
Bachelor's degree in computer science, Engineering, or related technical field. 8-10 years' experience in computer system validation within GMP-regulated pharmaceutical/biotech environments. 5-7 years with validating and creating URS documents for EMS and Client Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5. Proven experience validating EMS, Client, and laboratory informatics/data systems. Proficiency in authoring and executing FS/DS, IQ, OQ, PQ, and trace matrices. Experience performing ERES assessments and applying risk-based validation approaches. Familiarity with eQMS or informatics platforms (e.g., SciNotes, Blue Mountain, Empower, Lab Ware). Strong technical writing and documentation skills. Ability to manage parallel CSV activities in a compressed timeframe with accuracy and compliance.
Draft and execute URS for computerized facilities, utilities, and equipment systems. Perform and document risk assessments and ERES (Electronic Records and Electronic Signatures) assessments. Develop and execute validation deliverables: FS/DS, IQ, OQ, PQ protocols, and traceability matrices. Validate EMS/Client systems for environmental monitoring and building controls. Validate laboratory software platforms, including HPLC/qPCR data systems, SciNotes, and Blue Mountain (plus). Verify compliance with data integrity principles (ALCOA+), Part 11, and Annex 11 requirements. Document results, deviations, and resolution activities. Deliver complete GMP-ready CSV reports for QA review and approval. Collaborate with CQV Engineers, Technical Writers, and QA to ensure consistency across FEU, LEQ, and CSV validation workstreams. Requirements:
Bachelor's degree in computer science, Engineering, or related technical field. 8-10 years' experience in computer system validation within GMP-regulated pharmaceutical/biotech environments. 5-7 years with validating and creating URS documents for EMS and Client Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5. Proven experience validating EMS, Client, and laboratory informatics/data systems. Proficiency in authoring and executing FS/DS, IQ, OQ, PQ, and trace matrices. Experience performing ERES assessments and applying risk-based validation approaches. Familiarity with eQMS or informatics platforms (e.g., SciNotes, Blue Mountain, Empower, Lab Ware). Strong technical writing and documentation skills. Ability to manage parallel CSV activities in a compressed timeframe with accuracy and compliance.