Global Quality Engineering & Validation Lead - Medical Devices / IVDs (all genders)

Greiner Bio-One International; Kremsmünster; On-site; EUR 55,000 - 67,000; Full time

Job summary

Greiner Bio-One International is seeking a Senior Validation Lead to harmonize global validation strategies across manufacturing processes, sterilization, and methods. You will drive cross-site process transfers and assess regulatory impacts in FDA/ISO environments.

The role requires a degree in engineering or life sciences, 5+ years in regulated industries, and strong Quality Engineering knowledge. Fluency in English and good German are expected.

Qualifications

• Degree in Engineering, Life Sciences, Biotechnology or related field.
• 5+ years in Medical Devices, IVD or regulated industries.
• Strong Knowledge of Quality Engineering principles.
• Experience with FDA and ISO 13485 environments.
• Sterilization/radiation validation experience preferred.
• International manufacturing networks experience preferred.

Responsibilities

• Lead and harmonize global validation strategies for manufacturing processes, sterilization and methods.
• Drive compliant process transfers between international production sites.
• Assess the quality and regulatory impact of process changes.
• Provide expert guidance on Quality Engineering and validation requirements within FDA and ISO-regulated environments.
• Review and approve key global quality documents including validation and transfer master plans.
• Partner with Operations, Manufacturing, R&D, Engineering, Quality and Regulatory Affairs teams worldwide.
• Support the implementation of risk-based and state-of-the-art validation approaches across the organization.
• Serve as a global subject matter expert for validation.

Skills

Quality engineering

Process validation

Sterilization validation

Technology transfer

Regulatory experience

Stakeholder management

English proficiency

German proficiency

Education

Engineering degree

Life Sciences degree

Job description

Your challenge

• Lead and harmonize global validation strategies for manufacturing processes, sterilization and methods
• Drive compliant and efficient process transfer activities between international production sites
• Assess the quality and regulatory impact of process changes
• Provide expert guidance on Quality Engineering and validation requirements within FDA and ISO-regulated environments
• Review and approve key global quality documents including validation and transfer master plans
• Partner with Operations, Manufacturing, R&D, Engineering, Quality and Regulatory Affairs teams worldwide
• Support the implementation of risk-based and state-of-the-art validation approaches across the organization
• Serve as a global subject matter expert for validation

Your Profile

• Degree in Engineering, Life Sciences, Biotechnology or related discipline
• 5+ years of experience in Medical Devices, IVD or other regulated industries
• Strong knowledge of Quality Engineering principles
• Hands-on experience in process/sterilization/method validation and technology transfer
• Experience working within FDA and ISO 13485 regulated environments
• Strong stakeholder management and communication skills
• Fluent English and very good German skills
• Experience with radiation or sterilization validation preferred
• Experience in international manufacturing networks preferred
• Knowledge of MDR and/or IVDR preferred

Our Offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 60.977,70 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.