CQ Lead
- West Coast
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Excellent contract opportunity for a CQV engineer to lead the commissioning and qualification team of a multimillion dollar Bio-pharmaceutical capital project in the heart of San Francisco.
Our client is looking for an individual to be responsible for:
- Supporting the development of the project C&Q master plan, identify task lists and project time lines in line with the objectives and goals of the projects, and propose sub-plans to facilitate the C&Q process, and eliminate road blocks.
- Leading the project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.
- Aid with the C&Q cost and schedule planning and control process.
- Work closely with the contractor to help align the C&Q program with the construction program
- Ensure the successful handover to process validation activities.
- Lead a C&Q team (technical writers, commissioning engineers, interfaces to calibration and system owners) and manage day-to-day C&Q activities.
- Work closely with Automation/IT, Quality, Compliance and Technology Leads to ensure readiness for facility, process and clean utilities commissioning and qualification
- Ensuring C&Q program alignment with companies engineering best practices.
- Manage relevant project documentation
- Managing commissioning and qualification phase improvement (lessons learned, deviation management and resolution, etc.)
The requirements for this role:
- BS Engineering or Science (or equivalent experience)
- 8 years project experience in a CQ, Validation Role.
- Previous Biologics greenfield or brownfield experience in RV, IV and IQ generation (ASTM E2500 based approach) and execution an advantage
- Demonstrated leadership and people management skills.
- Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification
- Good written and verbal communication skills with both technical and non-technical staff
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Annabel
I manage this role.