Write and review validation (verification, IOQ, PQ, and PV) documents (protocols, reports, risk assessments, etc.), conduct or coordinate performance testing and perform or oversee the validation of facilities, equipment, utilities, laboratories, equipment, and processes. Involved in validation monitoring activities, which include audits with the system owner and review of operational documents. Participates in process development and process validation activities, including cleaning, shipping and continued process verification.
Essential Duties and Responsibilities:
- Write standard operating procedures describing process validation principles and activities as well as Validation Plans for functional areas and/or projects focusing on process and cleaning validation.
- Actively participate during all phases of process validation: evaluate projects, provide guidance and technical information to co-workers. Write and review validation documents to support FAT, commissioning, IOQ, PQ, PV activities including protocols and final reports.
- Write and review validation documents related to facilities, equipment, utilities, laboratories and equipment, or process validation systems comprising check for compliance with corporate standards, regulatory requirements and technical expertise.
- Review engineering drawings (P&IDs, against, as-built), TOP documentation.
- Review validation packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and bring exceptions and deviations to management's attention. Recommend to management as to the acceptance and release of qualified systems.
- Execute and/or coordinate/supervise execution of process, cleaning, shipping and continued process verification activities.
- Executes process validation for new processes as well as legacy processes and requalifications.
- All employees are responsible for the general upkeep of work and shared spaces.
- Other duties as assigned.