Commissioning and Qualification Scheduler
PharmEng Technology is currently seeking a Commissioning and Qualification Scheduler
for a project in Ontario, Canada. The position is available immediately conditional of a successful interview
- Develop and manage project schedules and associated project documentation
- Provide schedule analysis and schedule metrics on a weekly basis
- Support project managers by advising of schedule deviations from the project plan, analyse risk and contribute to the creation of recovery plans
- Integrate multiple schedules into the master project schedule
- Review schedules provided by external contractors, equipment builders and communicate changes, requirements and deviations to the master schedule
- Provide weekly reports on project status, project progress and schedule deviations, using information provided by multiple departments and external vendors
- Create high level reports to communicate project status, and support the Project Management Organization
- Experience with construction of industrial facilities, such as process plant, Nuclear facilities, Oil and Gas preferred
- Responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
- Able to lead CQV efforts around bio pharmaceutical manufacturing including CIP/SIP, Fermentation and purification systems, supporting utilities clean st4eam, WFI compressed air
- This position will support C&Q activities across the site as directed by site Technical Services management.
- Review site commissioning and qualification documentation for accuracy, technical soundness and compliance to both site and regulatory guidelines.
- Projects may include new facilities/equipment startup, commissioning, FAT, manufacturing equipment qualification, laboratory equipment qualification and computerized and automation systems including FMS and BMS systems.
- Provide support for the development of user requirement and functional specifications.
- Support the generation and execution of all commissioning and qualification documentation related to demonstration batches, thermal studies, validation studies for equipment, facilities, utilities, engineering test runs, development studies, software validation and final reports.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
- Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy)
- Microsoft Project and Oracle Primavera P6
- Experience within the pharmaceutical industry preferred
- Hands on experience with EPCM planning, creating and maintaining complex project schedules using Primavera P6
- Excellent understanding of schedule metrics and progress reporting
- Must be able to communicate schedule deviations and schedule logic at the appropriate level to different members of the project team
- Be able to report proactively schedule deviations on assigned tasks and the overall project
- Strong organizational skills and attention to detail
- Strong relationship-building ability, proactive, and resourceful
- Proactive and ability to work well with team and independently with minimal supervision
- Must have experience with qualifying clean utilities, HVAC System, Vaccine production equipment, production facilities and environmental validation
- Experience must include field execution of functionality testing, alarms and safety testing and integrated system t4estings
- Individual may be required to execute test or generate test scripts and report or a combination of all activities
- Facilities (including design, flow analysis, HVAC), Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems), major equipment, process / cleaning and equipment validation / qualification or computer software validation.
- Firm understanding of cGMP validation requirements / guidelines and current industry practice.