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Supervisor, Commissioning, Qualification and Validation
3 months ago
Department: Facilities and Engineering
Position Summary
As Supervisor, Commissioning, Qualification and Validation (CQV), you will lead day-to-day CQV activities such as the development and execution of qualification/validation of deliverable(s) and standard operating procedures (SOPs) by both internal and external resources. The person in this position provides group oversight by training, mentoring and supervising CQV staff to complete projects and departmental goals safely, efficiently and economically.
Responsibilities:
- Leads day-to-day CQV deliverable document development, which encompasses equipment; facilities; utilities; computerized systems; and cleaning 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 the Manufacturing Science and Technology, Process Development, Operations, Information Technology and Quality Assurance teams, and clients, to accurately develop documentation requirements.
- Directs and manages CQV internal staff, contractors and CQV consulting parties.
- Manages the preparations, revisions and updates schedule for validation activities.
- Performs departmental review of qualification-related documentation.
- Establishes and maintains a qualification documentation periodic review schedule.
- Develops SOPs, preventive maintenance and calibration programs.
- Develops and maintains temperature mapping requirements, protocols and schedules.
- Contributes to alarm rationalization assessments and management of required alarm documentation.
- Prepares and manages the timely completion of all departmental tasks, including deviations, change control, impact assessments, corrective and preventive action, and other associated records.
- Leads cross-functional personnel to develop documented risk assessments and mitigation strategies, as required.
- Monitors SOP periodic review cycle timelines to ensure timely review of CQV SOPs.
- Supports the environmental monitoring program.
- Contributes to facility cleaning strategies and compatibilities.
- Participates in regulatory, customer and internal audits as a subject matter expert.
- Meets all deadlines associated with projects as directed, including all reports and documentation.
- Keeps the Manager, CQV updated on all schedules, qualification testing results, and all other departmental activities.
- Performs regular 1:1s and performance reviews, obtain feedback and monitor employee’s progress toward achieving Objectives, offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance and a safe working environment.
- Ensures adherence of team members (direct reports) to all compliance programs and company policies and procedures.
- All other duties, as assigned.
Qualifications and Experience:
- 5+ years of experience in a related CQV position in a biopharma/pharmaceutical Good Manufacturing Practices environment.
- Previous experience with direct supervision of personnel preferred.
- Strong understanding of an aseptic manufacturing facility and cell manufacturing/viral vector-related equipment and technologies.
- Post-secondary education in engineering technology or similar qualification preferred.
- Strong English written and oral communication skills.
- Experience participating as a subject matter expert in regulatory inspections.
- Knowledgeable 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
