Description
A global biotech organisation require a team of Commissioning & Qualification (C&Q) Engineers, as part of the project start-up team for a new large capital biotech project. You will be part of a team responsible for the start-up of designated systems (both utility and process).
The role of the C&Q Engineer will be to:
- Successfully execute start-up activities safely and to a high quality, based on the overall C&Q schedule, for assigned systems.
- Familiarise oneself with all specific elements of the process and utility design for assigned systems. This to be achieved through documentation and drawing review with both EPCM and client team members.
- Generate/Execute/Review documentation (commissioning procedures) for assigned systems.
- Review/Approve documentation (vendor test documentation and automation test scripts) for assigned systems.
- Ensure that design intent is met and proven through the execution of start-up activities.
- Engage with technical support functions (ie process, automation etc.) to resolve issues quickly as they arise through C&Q execution.
- Train new operations personnel in system operations.
- Support subsequent (post OQ) validation and operations activities including but not limited to Cycle development, PQ and early batch production.
Experience required:
- Extensive experience in a process or start-up role in the Bio-pharmaceutical industry.
- Experience in pharmaceutical plant commissioning and qualification, preferably in a biotechnology process environment.
- Emerson Delta V automation system competency
- Literate in computer operating systems and applications such as Windows, MS Word and Excel.
- Qualified with relevant technology degree (or equivalent).
- Operating experience in the pharmaceutical industry, ideally in a biotechnology process environment.
- Knowledge of process & clean utility design.
- Temperature mapping experience
- Good understanding of the regulatory compliance requirements (EMEA/FDA) for biotech operations including area classifications, garbing etc.
- Results oriented engineer with good organisational skills.
Long term contract positions, working in a dynamic team, offering competitive rates of pay. Please apply now for more information.
Please contact Rebecca Church or email.