US - CQV Consultant

Responsibilities

• Write C/Q/V documents following established standards and templates, including but not limited to the following: CQV Master Plans, Commissioning Forms, CQV Protocols and Summary Reports, Standard Operating Procedures, Impact Assessments, Specifications (URS/FRS/DDS), FATs/SATs.
• Review various protocols, executed records and 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 and 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 CQV activities including ETOPs, protocol data packages, etc.
• Aid in deviation investigation and resolution for problems and issues encountered during field execution activities.

Qualifications

• Bachelor's Degree in Engineering, preferably Chemical or Biotechnology.
• High level of familiarity with MS Office package (Project, PowerPoint, Excel, Word).
• 3-4+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA.
• Experience in writing and execution of VMP, FQ, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems and Software.
• Must have experience with qualifying clean utilities, HVAC System, Vaccine production equipment, production facilities and environmental validation.
• Experience in industrial automation and system controls is a plus.