Sr. Cleaning Validation Engineer
Functieomschrijving:
As a Validation Engineer, as part of the project Validation team, you 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.
The role will involve working as part of the larger QA Validation organization and engaging with various groups and departments including manufacturing and quality.
Main tasks:
* 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
Profile:
Must haves:
* Scientific Bachelor/Master's degree
* 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
* 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
Nice to haves:
* Emerson Delta V automation system competency
* Knowledge of EU and US Pharmacopoeia
* Operating experience in the pharmaceutical industry, ideally in a biotechnology process environment
Offer as a consultant:
* A permanent contract with a competitive salary, complemented by a monthly fixed expense allowance, a company car and fuel card or a monthly gross bonus. Additional benefits include €8 meal vouchers, group and hospitalization insurance, a mobile phone subscription, and a year-end bonus.
* This package is further enhanced with access to Benefits at Work, sport & culture vouchers, and eco vouchers.
* You'll also benefit from a varied and dynamic training offering, including both job-specific and cross-functional courses
* Expect regular feedback and check-ins with your dedicated HR Business Partner
* Get to know your fellow consultants during our networking events and team-building activities
* Kickstart your career at USG Professionals with our two-day Bootcamp
Offer as a freelancer:
* Streamline your freelance career with the USG EASY app
* Receive personalized project proposals based on your profile and availability
* Enjoy transparent follow-up of your invoicing process
* Manage all your administration in one app
Company info:
USG Professionals connects the expertise and ambitions of highly educated professionals with the challenges of clients across six different fields: Engineering & Science, ICT, HR, Legal and Finance. We support our clients with temporary needs through project sourcing and with the permanent filling of open positions through recruitment & selection.