Responsibilities :
- Responsible for performing validation of computer systems, process automation, equipment, utility systems, and / or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
- Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
- Compiles and analyses validation data, prepares reports and makes recommendations for changes and / or improvements.
- May also investigate and trouble-shoot problems which occur and determine solutions.
- Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
- Maintains all documentation pertaining to validation.
- Will assist in developing procedures and / or protocols.
- Coordinates contract personnel through completion of assignments.
- Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
Requirements :
- Understanding and application of validation principles, concepts, practices, and standards. - 8+ years
- Working knowledge of current Good Manufacturing Practices (GMPs).
- Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
- 6+ years qualifying infrastructure and OT networks.
- Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
- Strong verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
- 6 of 8 skills match your profile - you may be a good fit.
- Requirements added by the job poster.
- 6+ years of work experience with Data Validation.
- 6+ years of work experience with Infrastructure.
- 6+ years of work experience with Data Acquisition.
Validation Engineer, Infrastructure Qualification
Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5. Compiles and ana...
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