Our client is the manufacturing branch (Vienna catchment area / Lower Austria) of an owner-managed pharmaceutical company that offers and develops original prescription drugs worldwide and is constantly growing through strategic acquisitions. With the aim of ensuring the long-term availability of its products, developing them further for the benefit of current and future patients, and supplying them worldwide, the biotech production site is being expanded dynamically and in line with the latest state of the art.

Currently, the company is looking for a highly motivated candidate for its biotech production site to fill the role as:

Validation Manager (f/m/x)

Lower Austria / Vienna Catchment Area

YOUR FUTURE ROLE

• Create plans and masterplans for PPQs and supportive validations
• Discuss and present the related plans to the relevant departments (QC / QA / RA & production)
• Collect, summarize, and evaluate the generated data from PPQ campaigns and supportive validations
• Evaluate manufacturing data according to official and GMP regulations using statistical methods
• Create PPQ Reports and supportive validation reports/studies, including risk assessments
• Work closely with RA, QM, and QC departments
• Present the validation in English and German during customer audits and inspections

JOB REQUIREMENTS

• MSc or equivalent Diploma in relevant field
• Professional experience (min. 2 years) in PPQ activities in complex chemical or biotechnological manufacturing
• Good understanding of biotechnological processes (USP and DSP)
• High level of practical knowledge in GMP
• Good understanding in technical field of manufacturing equipment in Biotech processes (USP, DSP)
• Good communication skills with the ability to understand the requirements of the QC/QA/RA departments and derive actions from them
• Strong analytical understanding in order to analyze data, precise personality
• Flexibility to quickly adapt to changes
• Good command in English and German (oral and written)

OUR CLIENT OFFERS

• Possibility to leave your own professional footprint, implement your own ideas and to make a change
• Work side by side with management in a dynamic, family-like, and inspiring corporate culture
• The salary range for this position starts at 70,000 – an overpayment is possible, depending on your qualifications and experience
• In addition, you will benefit from further training opportunities and attractive social benefits (including flextime working model, bridging days, meal vouchers, company car park, very good public transport connections and much more)

ARE YOU INTERESTED?

We are looking forward to receiving your application (English CV & cover letter incl. salary expectations) over the application-dashboard. Our responsible consultant will contact you immediately after receipt.
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