For our Client, a leading Biotech Company located at Düsseldorf, we are currently looking for this permanent position

Senior Manager (m/w/d) Engineering and Validation

Vertragsart: Festanstellung

Auftragsnummer: A540-847

Startdatum: 01.06.2019

Einsatzort: Nordrhein-Westfalen

Job-Beschreibung:


Ihre Aufgaben:

  • Responsible for the maintenance of validated state of facilities, manufacturing equipment, analytical equipment, clean utilities and computerized systems on the Düsseldorf site, including validation of the cleaning process
  • Ensures that the site validation program complies with global validation policies and directives
  • Owner of the Site Validation Master Plan (s)
  • Develops (as needed), reviews and approves documents, that need Validation input e.g. protocols, reports validation plans, SOPs, deviations, Like for Like assessments, etc.
  • Provides input into the equipment specifications, and relevant change orders for the validation activities
  • Ensures compliance of the Validation requirements before/after equipment and system interventions due to corrective or preventive maintenance actions
  • Trains department and other staff on the scientific, statistical and document design principles relevant to their work and performing employee appraisals and competency evaluations
  • Manages validation projects and department workload so that company project timelines are met
  • Responsible for collecting, analyzing and presenting Validation Quality Metrics data
  • Responsible for presenting validation work to internal and external auditors and regulators
  • Assists other departments with risk analyses and the development of specifications for utilities and equipment that will be qualified
  • Remains up-to-date with current federal and international regulations, guidance documents, standards and industry trends
  • Responsible for the setting and follow up of validation strategy and execution plans

Ihre Qualifikationen:

  • Hands on experience with qualification of facilities, manufacturing equipment, analytical equipment, clean utilities and computerized systems
  • Hands on experience with cleaning validation
  • Experience presenting site validation programs to regulatory agencies
  • Bachelor’s degree or higher in Chemical, Mechanical Engineering, or related scientific or technical discipline from an accredited technical university.
  • 5+ years of relevant work experience managing a validation department in a vaccine, biologicals, or parenterals pharmaceutical manufacturing environment.
  • Fluency in English and German both written and spoken
  • Working knowledge of current federal, local, and international regulations regarding the production of drug substances and drug products.
  • Good understanding of cGMPs, industry and regulatory standards and guidelines.
  • Good understanding of federal and local regulations regarding occupational safety and health within a manufacturing environment.
  • Excellent interpersonal skills and leadership potential.
  • Experience working with cross-functional teams.
  • Strong ethical foundation and a sound compliance understanding.
  • Experience managing teams.

Bei Fragen steht Ihnen Steffen Rademacher unter der Telefonnummer +49 211 92 410 190 gerne zur Verfügung.