K-RECRUITING Life Sciences Personalberatung - parallax image
K-RECRUITING Life Sciences Personalberatung - parallax image

K-Consultant 26080

K-RECRUITING – CONSULTANT PROFILE

Consultant 26080

Year of birth:1968
Language ability:German (native), English (business fluent)
Relevant knowledge:Project Management, Production & Manufacturing, Containment, Engineering, GMP, Risk Assessments, R&D, Pharmaceutical Industry, Machinery Manufacturing, Medical Devices, Qualification & Validation
Availability:asap, full-time, onsite

Experience

2015 - dato
Independent Consultant, Own Company

Freelance GMP, Quality & Production Expert

For relevant expertise, please see descriptions below:

03/19 - dato
Animal Health Company, Austria

Consultant for the project Technical controls for employee protection in the Pharmaceutical Product

  • Preparing concepts for a Bohle compact unit
  • Preparing the technical controls for the employee protection
  • Comprehension of GMP and Business aspects
  • Selection of suppliers
  • Cost and time estimation
01/19 - dato
Biotech Company, Switzerland

Project Engineer and responsible for a Sampling Booth (Class C)

  • Project planning and execution
  • Preparing URS / Business, GMP and safety requirements
  • Selection of suppliers
  • Cost determination
  • Cost control
  • Management of time and recourses
  • Implementation and commissioning


Project Engineer and responsible for an emergency container emptying station

  • Project planning and execution
  • Preparing URS / Business and safety requirements
  • Selection of suppliers
  • Cost determination
  • Cost control
  • Management of time and recourses
  • Implementation and commissioning
11/17 - 10/18
Chemical Company, Germany

Consultant for the project Battery production with toxic ingredients Planning for a plant over 3 levels

  • Planning of secondary containment (cleanrooms) for a battery production
  • Planning HVAC for the secondary containment (pressure zones, air change rate, particle minimization, safe change filters)
  • Selection of suppliers
  • Cost determination
  • Planning primary containment


Planning for a plant over 6 levels

  • Planning of secondary containment (cleanrooms) for a battery production
  • Planning HVAC for the secondary containment (pressure zones, air change rate, particle minimization, safe change filters)
  • Selection of suppliers
  • Cost determination
  • Planning primary containment
05/16 - 06/18
Pharma Company, Switzerland

Consultant for the project: High containment tablet press and reconstruction of a suitable production area

  • Engineering of the reconstruction measurements for implementation of the tablet press
  • General consulting for technical tasks in the department
  • Project lead for implementation of the tablet press, including all technical processes for with feeding with granule, sampling, bad tablet transfer, tablet dedusting, metal check and collecting the tablets


Project lead for all necessary reconstructions for operation of the tablet press

  • New purified water plant with loop, HVAC, waste water system and cleanrooms
  • Selection of a suitable containment tablet press and supplier
  • Project lead for the complete implementation
  • Determination of cost and cost control
  • Risk assessment for product safety
  • Risk assessment for employee safety
  • General consulting of technical tasks in the department
  • General consulting of GMP tasks in the department
04/16 - 09/17
Animal Health Company, Austria

Consultant for the project: Establishing of containment solutions for a GMP production (weighing to coating) and packaging plant

  • Development of the containment measurements under GMP aspects
  • Manufacturing building, material and personal locks, tablet press, weighing, granulation, coating and R&D equipment
  • Risk assessment for product safety
  • Risk assessment for employee safety
  • Costing, supplier selection
05/15 – 04/16
Institute for process technologies for polymer, chemical, petrochemical, pharmaceutical and food industries, Germany

Consultant for the project: Development of a prototype machine for a new method of drug production

  • Development of the machine
  • GMP consulting for the machine manufacturer
  • GMP Consulting for the pharmaceutical manufacturer
  • Risk assessment
  • Costing, supplier selection
  • Definition of the specifications
  • Creating specifications
07/14 – 02/16
Pharma Company, Germany

Consultant

  • Isolators for the manufacture of development batches with highly active substances in the field of weighing, mixing,
    tableting, drying and coating.
  • Advice on containment strategies for all production, cleaning and waste disposal operations
  • Planning the appropriate systems
  • Risk assessment
  • Creation of SOPs and BAs
12/14 – 02/15
Pharma Company, Germany

Consultant / Project Manager

  • Qualification of new equipment
  • Requalification
  • CAPA
  • Change control
  • Risk assessment
  • Creation of IQ, OQ plans
  • Commissioning, FAT/SAT
2014 – 2015
Consulting Company, Germany

Project Manager / GMP Consultant

05/13 – 07/14
Pharmaceutical Research & Development Institute, Germany

Project Manager/ part-project manager for the project Vacuum Roller Dryer

  • Technology development for the drying of highly active ingredients
  • Including agitator vessel for the manufacture of API and org. Solvents
  • Development of manufacturing process and the production flow under GMP aspects
  • Determination of the specifications
  • Identification and selection of suppliers
  • Cost plan
  • Setting of parameters and preparation of the measuring points lists
  • Risk assessment
  • Design configuration and development with the suppliers
  • Creation of specifications
  • Creation of IQ, OQ plans (not completed)
2008 – 2014
Pharmaceutical Research & Development Institute, Germany

Project Manager

  • Employed in research and development.
  • Project Manager for technical projects in the GMP and Containment field (GMP pilot plant renovation project).
  • Responsible for the containment technology.
  • Planning and implementation of the pharmaceutical equipment.
  • Validation and qualification of the equipment.
06/12 – 11/12
Medical Research Company, Germany

Project Manager for a bi-layer tablet press

  • Evaluation of tablet presses of different manufacturers for the usage in GMP field
  • Costing, supplier selection
  • Risk assessment
  • Creating SOPs
  • Creation of IQ, OQ plans
  • Installation of the systems
  • Carrying out FAT, SAT
  • Qualification / commissioning
  • Implementation training
01/09 – 11/11
Medical Research Company, Germany

Project Manager and part project manager for the project weight isolator

  • Installing of a stainless-steel isolator (SKAN) for the usage in GMP field
  • Definition of specifications
  • Creating specifications
  • Selection of suppliers, design configuration
  • Cost plan
  • Implementing Mock-Up
  • Risk assessment
  • Drawing up emergency procedure at product outlet
  • Creating SOPs
  • Installation of the system
  • Carrying out FAT, SAT
  • Commissioning
  • Implementation training
01/08 – 08/08
Medical Research Company, Germany

Project Manager for the reconstruction of a GMP pilot plant for the processing of highly active substances

  • Installation of soft wall isolators
  • Development of containment systems for the weighing, sieving, mixing, extrusion, tableting and coating
  • Supplier selection, design configuration, costing and price negotiations
  • Time planning
  • Risk assessments
  • Creating emergency procedure for accident product outlet
  • Creating SOPs
  • Creation of IQ, OQ plans
  • Installation of the systems
  • Carrying out FAT, SAT
  • Qualification / commissioning
  • Implementation training
1994 – 2007
Pharma Company, Germany

Part Project Manager for Containment and Automation

02/06 – 11/06
Pharma Company, Germany

Project Manager (staff side). Automation for fluid bed dryers and coater

  • Risk assessment
  • Development of the user interface
  • Development of control software
  • Installation
  • Creating SOPs
  • Creation of IQ, OQ plans
  • Qualification / commissioning
  • Implementation training