Commissioning and Qualification Lead
PharmEng Technology is currently seeking a Commissioning and Qualification Lead
for a project in Quebec. 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.
- Will work with Technical Services management, but be expected to perform required activities related to validation independently.
- Develop and execute computerized systems validation protocols (IQ/OQ/PQ). Validation Summary report, Data Transfer and Integrity Testing Protocol.
- Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
- Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP).
- Responsible for the validation (IQ, OQ, PQ) of various types of equipment systems: validation or requalification of autoclave loads, process equipment, filter integrity tester, depyrogenation oven loads, parts washer, vial washer, wireless temperature data loggers, temperature controlled chambers, lab analytical media fills, and Barrier isolators
- Experience with sterilization process validation and chamber qualification (Freezer, Refrigerators, etc.) is required.
- Evaluate new technological solutions determine feasibility, implementation and validation requirements.
- Must have experience with the generation of deviations and CAPAs.
- 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.
- Must be Bilingual
- Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy)
- 10 - 15 years of applied technical experience in the pharmaceutical or biotech industries.
- In addition, 10 years of hands on validation experience in at least two (2) of the following disciplines is preferred: 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.