Engineering |  Validation | Compliance | Regulatory Affairs | Production | 
Scientific Writing | Up-/Downstream & Fill Finish


(Lead) Project Engineers/Project Manager CAPEX: Feasibility, Conceptual Design, Basic/Detail Design | Management ad Interim


Equipment qualification documentation & execution |
Support process validation, Aseptic process Simulation, cleaning/sterilization validation, CSV

Production routine

CAPA Management, Preparing SOP/WI |
Operator training, Process/Equipment change |
Management ad interim

Production facility

Layout development of complete facilities or individual production suites/side functions. Preparation of material and personnel flow diagrams, hygienic zone concept, pressure concept, X-contamination assessments.

Production equipment

Preparing URS and further engineering documentation, incorporating the interdisciplinary project members/SME/process needs.
Tendering process and technical clarification with system supplier, review of design documentation and project management up to FAT/SAT.


Process mapping, conceptual design/adaption to new facilities, technical transfer, and scale-up.
Planning and execution of experiments, evaluation of results, and preparation of rationale/reports.


Engineering of pharmaceutical and biotechnological manufacturing facilities means facing all aspects of a production process in a very early and abstract stage right before production takes place.
While requirements of various departments need to be considered all activities are carried out anytime with respect to applicable guidelines of authority bodies and the principles of GMP.


Validation is the documented evidence that a process or a part of it leads to products which comply to all requirements linked to quality and thus to efficacy and safety.

A successful validation is not one option – it is mandatory.
Thereby the efforts needed for validation may notably depend on quality and providence of the engineering stage.


Preparation of qualification and validation documents. Review of relevant supplier documentation. Performing risk analysis.


Performing the test cases described in plans and documentation of results. Management of deviations.


Evaluation of results and creation of qualification and validation reports.

Production Routine

  • Head of Manufacturing ad interim
  • SOP – Preparing, adaption, and training of SOPs and Work Instructions
  • Planning and realization of Compliance projects
  • Preparation and execution of process changes including Quality Risk Assessment
  • Preparation and Assessment of Changes of Production Equipment
  • Deviation Management, respectively CAPA & EC Management (Trackwise, Veeva)
  • Annual Quality Review
  • Requalification and Revalidation


Trouble shooting during production; Process mapping and defining routine interventions; Preparation and execution of revalidation protocols; Batch record review

Deviation & CAPA Management

Effecting the Impact Assessments; performing the investigation and making up the Investigation Reports; Definition of CAPAs and ECs; Preparation of Risk Assessments for Production Processes…

SOPs and WIs

Preparation of comprehensible SOP for new Equipment; Revision of production SOPs and Work Instructions and adaption to established processes


We give support to pharmaceutical manufacturer to erect, to enlarge, or to refurbish their manufacturing capacities for Drug Substances and Drug Products in western Europe and ROW.

Our activities generally are subject to nondisclosure. Regarding our customers interests deeper insights might be given upon prior consulting the customer, and nondisclosure agreement. Please ask for.

Example Case 1: Green field


New multipurpose facility for liquid and lyophilized vials: Define Requirements, procurement process for equipment and services, monitore and communicate progress, supervision of project team, coordinate supplier and service provider, preparing engineering and qualification  documentation, perform qualification for various production equipment.

Example Case 2: Routine Production

Improvement of a running filling line to achieve sterile conditions, and getting the line registered by the FDA.

Assure equipment availability for ongoing production. Bring expertise into a young team of production engineers and give support to ENG, Qual/Val, Compliance, and Production.

Example Case 3: Scientific Writing

Compiling a part of the application Dossier for marketing authorization

Edit chapter 3.2.P.2.4 – Container Closure System of Module 3 of the Common Technical Document. Document and assess the potential risk from a quality point of view by usage of polymeric single use equipment introduced into the filling process after the sterile filtrations of parenterals. Especially regarding Leachables and Extractables.

We are the team

We are a dynamic team of junior and senior professionals. All with main emphasis on pharmaceutical industry with its very specific aspects of Quality. We always stay open for changing statutory requirements, progress regulatory procedures, and technological changes.

Located in the south western part of Germany between Heidelberg and the French boarder it’s only a stone’s throw from pharma hot spots Basel region, Strasbourg, or the Rhine-Main Area with global players like Roche, Novartis, Lonza, Eli Lilly, Sanofi-Aventis, Merck, Abbott, Boehringer-Ingelheim, Fresenius.

Always seeking for both, experienced and young professionals to strengthen our team we aspire to live and foster diversity, equity, and inclusion every day.

Olivier Faber

Olivier Faber

Sr. Process & Qualification/Validation Engineer, General Manager

Johannes Axt

Johannes Axt

Jr. Process & Qualification Engineer

Markus Puschmann

Markus Puschmann

Sr. Consultant Quality, Qualification & Documentation Engineer


We can rely on a long history of successful collaboration with partners and system suppliers for the pharmaceutical industry. 


Sepro Pharmenex – Quality, Safety, Reliability

Sepro Pharmenex unterstützt die pharmazeutischen Hersteller bei der Realisierung  ihrer Vorhaben für den Aufbau, die Erweiterung oder Erneuerung der für die Herstellung von Wirkstoffen und Arzneimittel erforderlichen Einrichtungen und leistet damit einen Beitrag zur Versorgung von Patienten mit sicheren Arzneimitteln.

Partner für Dienstleistung in der pharmazeutischen und medizintechnischen Industrie.


Sepro Pharmenex GmbH & Co. KG
Dipl.-Ing. (FH) Olivier Faber
Lindelbrunnstr. 61
76829 Landau

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