Head of Downstream Processing (DSP) Manufacturing

GXP CONSULTING Switzerland; Mittelwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a QA Validation Manager to ensure robustness and GMP compliance of critical processes. You’ll act as a key link between MSAT, Manufacturing and the client, delivering sound, well-documented evidence of process control.

Drive validation of biotechnological processes in a low-bioburden environment, oversee qualification of equipment and cleaning, ensure CPV, and support audits by European authorities and FDA. Fluent English is required; German is a plus.

Qualifikationen

• Bachelor's degree in Science, Biotechnology, or a related field.
• 5–7 years of experience in the pharmaceutical industry within a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment/system qualification.
• Experience with change controls, deviation management, and non-conformity investigations.
• Understanding of cell & gene manufacturing processes and low-bioburden environments.
• Fluent English required; German is a plus.

Aufgaben

• Drive validation of biotechnological processes in a low-bioburden (cell & gene) environment.
• Oversee qualification of related equipment and systems, as well as validation of manual and automated cleaning/sanitization processes.
• Ensure ongoing continuous process verification (CPV) and ownership of validation activities.
• Serve as the go-to QA contact for product transfer projects and related validation strategy.
• Carry out change control and deviation impact assessments, and support non-conformity investigations.
• Review and approve GMP documentation: protocols, reports, SOPs, change controls, deviations (process validation, cleaning, CSV).
• Act as subject matter expert for SOPs covering process and cleaning validation.
• Take part in audits and inspections (European authorities and FDA).
• Contribute to continuous improvement initiatives and the data integrity program.
• Participate in risk assessments.

Kenntnisse

Fluent English

German (nice to have)

Ausbildung

Bachelor's degree in Science/Biology/Biotech

Jobbeschreibung

Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.

To support a client, a major player in the biotech industry, we are looking for a QA Validation Manager, responsible for the robustness and GMP compliance of critical processes. You'll act as a key link between MSAT, Manufacturing and the client, providing sound, well-documented scientific evidence of process control.

Your impact :

• Drive validation of biotechnological processes in a low-bioburden (cell & gene) environment
• Oversee qualification of related equipment and systems, as well as validation of manual and automated cleaning/sanitization processes
• Ensure ongoing continuous process verification (CPV) and ownership of validation activities
• Serve as the go-to QA contact for product transfer projects and related validation strategy
• Carry out change control and deviation impact assessments, and support non-conformity investigations
• Review and approve GMP documentation: protocols, reports, SOPs, change controls, deviations (process validation, cleaning, CSV)
• Act as subject matter expert for SOPs covering process and cleaning validation
• Take part in audits and inspections (European authorities and FDA)
• Contribute to continuous improvement initiatives and the data integrity program
• Participate in risk assessments

What you bring :

• Bachelor's degree in Science, Biotechnology, or a related field
• 5–7 years of experience in the pharmaceutical industry, within a GMP-regulated environment
• Strong knowledge of process validation, cleaning validation, and equipment/system qualification
• Experience with change controls, deviation management, and non-conformity investigations
• Understanding of cell & gene manufacturing processes and low-bioburden environments
• Fluent English required; German is a plus

About us :

• Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
• We do care about our people, communicate openly and value feedback
• Work as a team where every member is valued and appreciated
• Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
• Continuous learning and development opportunities via internal or external training and workshops
• Competitive salary package in line with industry practice together with exceptional employment benefits

At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!

If you also share the same passion and values, we will be glad to hear from you!