Available to hire
Hi, I’m Rafael Klenk. I am a pharma engineering professional focused on leading multidisciplinary teams to deliver complex facilities and manufacturing trains for peptide and biologics production.
I bridge engineering, automation, QA and manufacturing to optimize CAPEX and project timelines. Outside work I enjoy traveling, sports, and exploring Latin America, Africa, and beyond.
Language
German
Fluent
English
Advanced
Spanish; Castilian
Advanced
French
Intermediate
Portuguese
Intermediate
Work Experience
Process Lead - Tyche Project at Pharma Engineering Klenk GmbH
August 1, 2024 - October 1, 2025Responsible for all process-related work packages (Filter Dryers, Reactors, HPLC Columns, Skids, Lyophilisators) with deliverables including RFQ review and support for Long Lead item ordering; cost, quality and time management within own discipline; expediting of time-critical activities; lead & manage engineers and specialists; participate and lead workshops at CPC site in USA.
Senior Engineer (RFQ Tyche CD Phase) at Pharma Engineering Klenk GmbH
June 1, 2024 - July 31, 2024Project Coordinator / Senior Engineer for RFQ phases for various CPI projects; creation of RFQ deliverables incl. assessments and tender evaluations.
Project Leader – Lyophilisation Process at Bachem AG
June 1, 2023 - May 31, 2024Project Leader for Lyophilisation process including cleanroom planning of various peptide manufacturing trains for multi-discipline coordination (Automation, Process, Quality); management of equipment: Lyophilisators, Isolators, Mixers, Clean Room and Piping, Filter Dryers, Reactors; single point of contact for design, technical, contractual and cost questions; organized changes in overall schedule.
Project Leader – Washing/ Sterilization Area at CSL Behring
March 1, 2022 - May 31, 2023Project Leader in Washing/ Sterilization Area; responsible for washers, autoclaves and small equipment within assignment of Exyte (Pharmaplan) including engineering/qualification documents.
Automation Engineer (MES/DeltaV) at Lonza AG (PP) Bioatrium
July 1, 2021 - December 31, 2021Creation of generic recipes for media preparation and control of development and engineering batches; electronic batch record review and implementation of generic recipes to accelerate manufacturing processes.
Scheduling Engineer (Planner) at Lonza AG (PP) Bioatrium
March 1, 2021 - July 31, 2021Three projects in Bioatrium including TCR- and T-Card meetings; scheduling in MS Project and Primavera P6; tracking module implementation.
Bioprocess Engineering at Lonza AG (PP) / Bioatrium
September 1, 2020 - March 31, 2021Qualification of SUB and Bioreactors in USP and Qualification of Chromatography Columns in DSP at Bioatrium in Lonza, Visp (PP) - Preparation of Commissioning protocols for different equipment.
Intern – Master Thesis in API Engineering at F. Hoffmann-La Roche
January 1, 2019 - July 1, 2020Master thesis in API Engineering: SUT for Bulk Material Handling; Containment studies of SUA; Contamination studies of SUA and corresponding calculations.
Intern – Cleaning Validation at F. Hoffmann-La Roche
May 1, 2018 - October 31, 2018Internship in Cleaning Validation: CSV Validation of cleaning validation protocols and corresponding documentation.
Assistant to Project Leader Cryo-infrastructure at Institute for Technical Physics, KIT Campus Nord
January 1, 2014 - May 1, 2019AutoCAD P&ID, Comsol Multiphysics; Creation of PIDs for media systems; Simulation processes of superconductors.
Intern at Astorplast Pfahlbronn
June 1, 2011 - July 31, 2011Process Scheduling for Polymer Stripes.
Education
Master of Science in Chemical Engineering at Karlsruhe Institute of Technology (KIT)
September 1, 2017 - April 1, 2020Bachelor of Science in Chemical Engineering at Karlsruhe Institute of Technology (KIT)
October 1, 2012 - August 1, 2017Bachelor of Science in Geoecologics at Karlsruhe Institute of Technology (KIT)
October 1, 2011 - September 1, 2012Qualifications
CSV Validation Training
May 1, 2018 - October 31, 2018Master Thesis in API Engineering
January 1, 2019 - July 1, 2020Industry Experience
Life Sciences, Manufacturing, Healthcare, Professional Services
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