Resolute Workforce Solution (a subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change.
We serve businesses in a wide range of industries including Pharmaceuticals, Medical Cannabis, Food & Beverage, Chemicals, and Information Technology.
We are looking for highly motivated and energetic individual to join our team / parent organization as a Commissioning & Qualification Consultant in Richmond Hill.
Travel will be required.
Write C / Q / V documents following established standards and templates, including but not limited to the following :
CQV Master Plans
CQV Protocols and Summary Reports
Standard Operating Procedures
Specifications (URS / FRS / DDS)
FATs / SATs
Review various protocols, executed records, reports that are generated during commissioning (FAT or SAT), validation activities (IQ, OQ, PQ, PV) for process equipment, facility and utility systems to ensure compliance with company quality policies and regulatory requirements.
Able to lead CQV efforts around biopharmaceutical manufacturing including CIP / SIP, Fermentation and purification systems, supporting utilities clean steam, WFI compressed air
Provide technical assistance during investigations of process / equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformances
Provide compliance expertise and leadership for projects involving commissioning, qualification, and validation of process equipment, facility, and utility systems.
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.
Perform the role of Validation Representative in review of Change Control Requests (CCR's) and CAPA.
Compile data and prepare reports for completed C / Q / V activities including ETOPs, protocol data packages, etc.
Assists in deviation investigation and resolution for problems and issues encountered during field execution activities.
Minimum requirement for this position is a bachelor's Degree in Engineering, preferably Chemical or Biotechnology
High level of familiarity with MS Office package (Microsoft Project, PowerPoint, Excel, Word)
Minimum of 5 years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA.
Experience in writing and execution of PFC, FC, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems and Software.
Must have direct experience in leading commissioning and validation projects, developing and executing commissioning and validation protocols, reviewing technical documents, and generating final reports as related to pharmaceutical equipment, facility, utility systems
Experience in industrial automation and system controls is a plus
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.
Upon successful completion of probation, you will also be enrolled in our benefit programs :
Long Term Disability
Dental and Healthcare