US - CQV Consultant

CQV Consultant

Client:
Brevitas Corp. Our Global Company, Brevitas Corp., 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, Food & Beverage, Chemicals, and Information Technology. We are looking for highly motivated and energetic individual to join our team as a CQV Consultant in Boston area, MA.

This job is located in the United States and only candidates eligible to work in the US for any employer will be considered. Travel will be required. By applying to this job your profile will be considered for upcoming roles within the next 1-6 months when opportunities do arise.

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.
• 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.
• Assist 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.
• Must have experience with field execution of functionality testing, alarms and safety testing and integrated system testing.
• Experience in industrial automation and system controls is a plus.
• Individual may be required to execute test or generate test scripts and report or a combination of all activities.