Expert Validation Engineer
vor 1 Monat
We are seeking a highly skilled Expert Validation Engineer to join our team at Vality One Recruitment GmbH. As a key member of our team, you will be responsible for ensuring the qualification of production equipment and laboratory devices under GMP conditions.
Key Responsibilities- Qualification of Production Equipment: Ensure that production equipment and laboratory devices are qualified and validated to meet GMP standards.
- Process Validation: Validate processes and ensure that they are compliant with GMP regulations.
- Validation of Sterilization Processes: Validate sterilization processes in autoclaves to ensure that they meet GMP standards.
- Validation and Optimization Projects: Lead and participate in validation and optimization projects to improve process efficiency and quality.
- Deviation Management: Identify, report, and resolve deviations in a timely and effective manner.
- Collaboration with Cross-Functional Teams: Work closely with cross-functional teams to ensure that GMP requirements are met.
- Document Control: Create and review GMP documents and SOPs to ensure that they are accurate and up-to-date.
- International Technology Transfer and Scale-up Projects: Participate in international technology transfer and scale-up projects to ensure that they meet GMP standards.
- Technical Change Management: Implement and document technical changes to equipment and processes.
- Root Cause Analysis: Lead and participate in root cause analysis to identify and resolve issues.
- Audit Preparation: Prepare for and participate in audits to ensure that GMP requirements are met.
- Education: Bachelor's degree in Engineering (preferably Process Engineering or Pharmaceutical Engineering).
- Experience: Several years of experience in validation and qualification in the pharmaceutical industry.
- Knowledge: In-depth knowledge of GMP regulations and guidelines.
- Skills: Strong analytical and problem-solving skills, ability to work independently and as part of a team.
- Language: Fluent in German and English.
Vality One Recruitment GmbH is a leading recruitment agency specializing in the life sciences industry. With over 20 years of experience, we have a deep understanding of the industry and a proven track record of delivering high-quality candidates to our clients.
We are a family-owned business that values innovation, creativity, and teamwork. We offer a dynamic and supportive work environment, flexible working hours, and a comprehensive benefits package.
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