About OmniaBio:
OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput. This innovative approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. OmniaBio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting-edge therapies worldwide. Visit www.omniabio.com to learn more.
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.
Participates in internal audits as a subject matter expert.
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
