Validation Manager (m/f/d)

TN Germany; Biberach an der Riß; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Join a leading company in the pharmaceutical industry as a Validation Expert in Biberach. You will be responsible for supporting products in process and cleaning validation, ensuring compliance, and collaborating with interdisciplinary project teams. This role offers an attractive salary package, bonuses, and opportunities for professional development.

Leistungen

Attractive salary package with bonuses

Reimbursement of travel expenses

Up to 30 days vacation per year

Development of skills

Qualifikationen

• Several years of professional experience in pharmaceuticals or biotechnology.
• Fluent in German and very good English skills.

Aufgaben

• Coordinate validation activities and independent planning of validations.
• Evaluate manufacturing/cleaning process changes regarding validation relevance.

Kenntnisse

GMP Knowledge

Communication

Teamwork

Organizational Skills

Initiative

Ausbildung

Master's degree in natural sciences/technical field

Bachelor's degree/scientific training

Tools

MS Office

SAP

TrackWise

Jobbeschreibung

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Get started now as a pharmacist with Randstad professional solutions! Our friendly colleagues in Biberach also have the right position for you. We are currently looking for a Validation Expert on behalf of our business partner in the pharmaceutical industry. Apply today and start your new job tomorrow! We actively embrace diversity, which is why we welcome all applications.

Here's what we offer

• Attractive salary package with Christmas and vacation bonuses
• Reimbursement of travel expenses
• Up to 30 days vacation per year
• Development of skills
• Responsibility for supporting products in process and cleaning validation, including representation in interdisciplinary project teams, compliance, and customer meetings (internal or external)
• Coordination of validation activities
• Independent planning of process and cleaning validations, including creation, maintenance, or revision of validation documents (validation master plans, validation reports, sampling plans, risk analyses) in coordination with relevant interfaces, primarily in English, including cooperation during deviations
• Research and GMP-compliant evaluation of analytical and operational results and data, e.g., from electronic systems
• Collaboration on control strategy, risk analysis, and other documents with development, production, analytical units, or other relevant interfaces
• Evaluation of manufacturing/cleaning process changes regarding validation relevance
• Evaluation of deviations related to process and cleaning validation
• Creation, maintenance, and revision of submission documents, including responding to authority inquiries about process and cleaning validation
• Representation of validation topics during audits and inspections
• Role of change manager in change management if required

Your profile

• Master's degree in natural sciences/technical field with several years of professional experience, or Bachelor's degree/scientific training with extensive GMP experience in pharmaceuticals, biotechnology, or process and cleaning validation, preferably in active ingredient production
• Several years of experience in biopharmaceutical/pharmaceutical/process engineering
• Comprehensive GMP knowledge and understanding of regulatory requirements
• Proficiency in MS Office applications
• Experience with SAP and/or TrackWise is advantageous
• Fluent German and very good English skills, both written and spoken
• High initiative, flexibility, and sense of responsibility
• Independent, structured working style with high commitment
• Assertiveness, communication, teamwork, organizational skills, and social competence
• High quality awareness and willingness to learn about process technology