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
- 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
- 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.