Specialist Validation and Qualification (m/f/d)

Norbitec GmbH was founded in 2003 as a joint venture and is a company of BIOCEUTICALS Arzneimittel AG, a subsidiary of STADA Arzneimittel AG and Nordmark Pharma GmbH. We are a successful biotech pharmaceutical company with around 120 employees and specializes in the production of a high-quality pharmaceutical active ingredient for the international market. We are currently on a healthy growth course and are therefore looking for reinforcement for our team. Specialist Validation and Qualification (w/m/d) Uetersen | Germany (DE) | Full time | Other Technical Operations | Professional

To strengthen our team, we are looking for a motivated personality in the field of qualification and validation, who wants to develop professionally in a GMP-regulated environment. You first, check and advise qualification and validation documents (e.g. URS, RA, DQ/IQ/OQ/PQ, reports) You accompany training and validation projects as part of the project team You check calibration and maintenance plans and follow the timely execution You are involved in the preparation and testing of cleaning validation documents You evaluate deviations, change controls and CAPAs related to qualified or validated systems You support re-qualifications and periodic reviews You agree with engineering, IT, QA/QC, production and external service providers You prepare internal and external audits/inspections and accompany them You secure the documentation according to GMP and internal specifications

You have a degree in engineering, natural science, pharmacy or a comparable qualification You bring professional experience in the field of qualification/validation in a GMP-regulated environment with You have good knowledge of relevant regulations (e.g. EU-GMP, Annex 15, Annex 11, 21 CFR Part 11) You have experience in handling technical equipment, laboratory or production systems You work structured, carefully and independently. You draw from communication strength and team skills You master German very well and English well – in both words and writing

Great team with flat hierarchies and open doors and ears Structured and extensive integration by an experienced team Attractive remuneration according to chemistry collective agreement, incl. Christmas and holiday allowance as well as bonus and childcare allowance, employer-funded pension, corporate benefits, long-term account, work physician, canteen (breakfast and lunch offers), sufficient free parking, JobRad and company fitness membership via EGYM Wellpass 30 days holiday + optional further 5 days after the collective agreement „Moderne Arbeitswelt“ + up to 6 fixed days of bridge (at 38.5 h/week – on full-time basis; per year) Professional and personal training Various offers for health and work-life balance (operational sports, massages, free external life advice)