The CQV Engineer, as part of the project Validation team, will be responsible for the timely qualification of assigned systems. This includes a large variety of systems, being the typical biopharmaceutical processing systems (bioreactors, centrifuges, buffer/media vessels, chromatography columns, filtrations skid etc.) as well as utilities, HVAC, parts washers and autoclaves.
The role will involve working as part of the larger CQV organization and engaging with various groups and departments including construction, manufacturing, quality, engineering and commissioning.
Responsibilities
* Participate in the project Validation team to successfully execute start-up activities safely and to a high quality, based on the overall CQV schedule, for assigned systems.
* Generate Validation documents (URS, Impact Assessments, IQ/OQ Protocols) for assigned systems in the paperless documentation system Kneat. The applied validation methodology is according to EU (Annex 15) and US (21CFR210/211/600) GMP regulations as well as specific internal company quality requirements.
* Verify technical documentation (i.e. welding and material packages as delivered by vendors as well as passivation, air break and IO verification sheets documented by commissioning) as part of IQ execution.
* Execute ‘as built’ field verifications based on P&ID’s.
* Generate IQ/OQ reports for the executed qualification tests.
* Ensure that design intent is met and proven through the execution of start-up activities.
* Report at regular times on progress.
* Engage with technical support functions (i.e. process, automation etc.) to resolve issues quickly as they arise through qualification execution.
Experience:
Essential
* Knowledge of pharmaceutical plant qualification, preferably in a biotechnology process environment.
* Knowledge of process & clean utility design.
* Good understanding of the regulatory GMP requirements in EU and US for biotech operations (such as Eudralex, ICH, 21CFR) including area classifications (ISO 14644 and EU Annex 1).
* Literate in computer operating systems and applications such as Windows, MS Word and Excel.
Preferred
* Qualified with relevant technology degree (or equivalent).
* Emerson Delta V automation system competency.
* Knowledge of EU and US Pharmacopoeia.
* Operating experience in the pharmaceutical industry, ideally in a biotechnology process environment.
* Specific for this profile: relevant experience in qualification of HVAC, cleanrooms (incl. thermo-mappings), LAF systems, Clean Utilities, Parts Washers and Autoclaves.
Personal / Team Skills:
* Able to communicate and write documentation in English.
* Results oriented with good organizational skills.
* Strong quality and safety focus
* Excellent communication skills
* Previous experience working in a team based environment