Description:
The Validation Engineer, as part of the project Validation team, will be responsible for the timely validation of cleaning processes. This includes a large variety of CIP processes on the typical biopharmaceutical processing systems (bioreactors, centrifuges, buffer/media vessels, filtrations skid etc.) as well as parts washers cleaning. Hands-on activity envisaged in relation to this (e.g. swabbing activities)
The role will involve working as part of the larger QA Validation organization and engaging with various groups and departments including manufacturing and quality.
General Scope of Responsibilities
Documentation cleaning validation protocol/reports
Scheduling of cleaning validation within production schedule
Support and coordinate physical testing
Provide expertise and participate in troubleshooting within team (Manufacturing, QA)
Cross-functional communication
Requirements
Essential
Knowledge of pharmaceutical plant qualification, preferably in a biotechnology process environment.
Knowledge of cleaning validation, including the CIP/COP methodology.
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.
Personal / Team Skills:
Essential
Able to communicate and write documentation in English and Dutch.
Results oriented with good organizational skills.
Able to working in an very flexible schedule.
Strong quality and safety focus
Excellent communication skills
Previous experience working in a team based environment