Associate I/ii, Commissioning, Qualification and Validation
1 week ago
**Position Summary**
The Associate I, Commissioning, Qualification and Validation, supports activities including development of validation master plan(s), and qualification/validation of deliverable(s) and standard operating procedures (SOPs). Responsibilities include assessment and development of qualification documentation for the facility, equipment and systems, and ensuring the documentation and equipment is compliant for manufacture to Good Manufacturing Practices (GMP) standards.
**Responsibilities**:
- Validates master plan and deliverable development, including equipment, facilities, utilities, computerized systems and processes, installation qualification, operational qualification, and performance qualification. Ensures these documents meet the minimum regulatory requirements at an appropriate level of validation.
- Collaborates with key stakeholders and user groups, including Manufacturing Science and Technology, Process Development, Operations, Information Technology and Quality Assurance, to accurately develop documentation requirements.
- Maintains the validation activities schedule.
- Contributes to the development of SOPs, preventive maintenance and calibration programs.
- Prepares temperature mapping protocols and summary documents.
- Contributes to alarm rationalization assessments and management of required alarm documentation.
- Supports completion deviations, change controls, impact assessments, corrective and preventive actions and other associated records.
- Supports the development of risk assessments and mitigation strategies.
- Completes periodic review of commissioning, qualification and validation (CQV) documentation/SOPs.
- Meets all deadlines associated with projects as directed, including all reports and documentation.
- Keeps the Manager, Commissioning, Qualification and Validation,, updated on all schedules, qualification testing results, and all other departmental activities.
- All other duties, as assigned.
**Qualifications and experience**:
- 1+ years of experience in a related CQV position in a biopharma/pharmaceutical GMP environment.
- Post-secondary education in engineering technology, or similar qualification, is preferred.
- Previous experience with CQV activities.
- Knowledge of clean room qualification and environmental monitoring requirements.
- Knowledge of the regulatory guidance for related aseptic, cell and gene therapy and regenerative medicine (e.g., Health Canada, U.S. FDA, EMA, ICHQ7, GAMP5, 21 CFR Part 11, ISPE, EU Annex, USP
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