Commissioning and Qualification
PharmEng Technology is currently seeking a Commissioning and Qualification
for a project in Canada, ON The position is available immediately conditional of a successful interview
- 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 steam, 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.
- Recommends to management as to the acceptance and release of qualified systems.
- Actively participates during all phases of validation projects. Evaluates projects, provides technical information to others.
- Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues.
- Review various documentation and drawings to ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.
- Provide technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformances.
- Support, investigate and troubleshoot problems and determine possible solutions.
- Provide effective solutions for the management of system deviations and non-conformances.
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)
- 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 testings
- 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.