DSP Process Expert / Pharmakant – Downstream Processing, Validierung & GMP (m/f/d)

This internationally leading pharmaceutical company specialises in the development, production and distribution of high-quality generic drugs and innovative medicines. At the Ulm site, state-of-the-art medicines and health solutions are researched and produced to improve patient care worldwide.

For this company we are looking for you as: DSP Process Expert / Biotechnologe / Process Engineer (m/w/d) - Downstream Processing, Validation & GMP

Deadline for 18 months

????? Own planning, implementation and documentation of process and cleaning validations (PV/RV) including risk analyses ????? Development and implementation of process optimization as well as creation and processing of amendments (Change Controls) ???? Working on data integrity risk analyses and evaluating data flows to ensure regulatory requirements ???? Creation, revision and maintenance of standard work instructions (SOPs), manufacturing regulations and GMP documentation ? Special responsibility as Process Subject Matter Expert (SME) for deviations, process adaptations, optimization measures and the processing of corresponding TrackWise-Records Implementation and documentation of selected production processes in downstream processing, for example chromatography, tangential flow filtration (TFF) or filling processes ???? Support for Batch Record Reviews, Trend Analysis and GMP-compliant release documentation ?????? Representation of the department as SME in internal and external audits as well as government inspections ? Support in the implementation and continuous improvement of GMP compliance and quality requirements in the field of DSP

Completed vocational training in the pharmaceutical sector as e.g. pharmacist/biology laboratory / pharmacist technical assistant (m/w/d) possibly a degree as a Bachelor or an art related profession with multiannual professional experience in the pharmaceutical sector, in particular downstream processes Multiannual experience in downstream processing (DSP), protein cleaning or biopharmaceutical production, ideally focusing on process transfer, process validation or process optimization Knowledge of Chromatography, TFF (Tangential Flow Filtration), Protein Purification, GMP, Change Control, TrackWise, Batch Record Review, Data Integrity and Regulatory Requirements Experience in the creation and maintenance of SOPs, manufacturing regulations and GMP documentation and in the processing of quality-relevant processes Analytical thinking, pronounced quality awareness and a structured and independent working with high self-responsibility Communication strength and joy in cooperation with interdisciplinary teams and international interfaces Language knowledge in German (C1) and good language skills in English (B2)

We pay a collective salary which is based on the IG BCE, as well as, if necessary, industry supplements, holiday and Christmas money as well as shift supplements according to the GVP tariff agreement. Your employment contract is unlimited. In cooperation with Allianz and the Nuremberg Insurance, we offer an occupational pension scheme. You will receive a high-quality professional equipment for protective and workwear as well as medical precautions by the Werksarztzentrum. If necessary, we finance individual training courses that will continue to take you in the long term. As an expert employee you get exclusive discounts in over 600 shops and online shops. We will also be happy to advise you on other advertised positions and career opportunities. .