CQV Engineer
4 weeks ago
Pharmaceutical & Life Sciences
Company: PES International
Location: Boston, MA
Compensation: Commensurate with Experience
About this opportunity:
PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge based in these specialist areas from initial concept design through to commissioning and qualification of your facility. We're actively building out our US presence and looking for talented team members to work with us in delivering critical project management consultancy expertise.
This role will be responsible for ensuring that all systems, facilities, and equipment are installed properly and meet the design requirements put in place for the end-users in a pharmaceutical facility (laboratory and manufacturing). The CQV engineer will document the process of installation, operations, and how the equipment performs. This position will be responsible for supporting project plans aligning with GMP.
What we're looking for:
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, or relevant degree, or equivalent years of hands-on experience
- 5+ years of experience in commissioning, qualification and validation in pharma or biotech industries
- Experience in the areas of design documentation, validation (IQ/OQ/PQ, etc.), quality systems, and equipment startup
- Able to collaborate with cross-functional team members including engineering, quality, and manufacturing to develop and support comprehensive CQV strategies and plans for the pharmaceutical project
- Ability to support site validation planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, cleaning, packaging processes
- Work and interact with cross-functional team members
- Problem solving and troubleshooting ability
- High attention to detail
- Strong written and verbal communication skills interacting with variety of customers, vendors, equipment suppliers, and other team members
- Able to travel to client sites and domestically
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