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Advanced Quality Validation Engineer
2 months ago
We are seeking a highly skilled Advanced Quality Validation Engineer to join our team at Bio-Techne. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes.
Key Responsibilities- Develop and implement validation protocols for manufacturing equipment, facilities, and laboratory instruments.
- Conduct risk assessments and develop risk-based validation plans to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and implement process improvements and optimize manufacturing operations.
- Provide technical expertise and guidance to colleagues on validation-related matters.
- Develop and maintain documentation, including validation reports, protocols, and procedures.
- Ensure compliance with regulatory requirements, including cGMP, ISO 9001, and ISO 13485.
- Participate in internal audits and regulatory inspections to ensure readiness and compliance.
- Stay up-to-date with industry developments and regulatory changes, and implement best practices in validation and quality assurance.
- Bachelor's degree in Engineering, Life Sciences, or a related field, with a minimum of 5-10 years of relevant experience in validation and quality assurance.
- Proven expertise in validation, quality assurance, and regulatory compliance, with a strong understanding of cGMP, ISO 9001, and ISO 13485.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions.
- Ability to work in a fast-paced environment and prioritize multiple tasks and projects.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
- Recognition and rewards for outstanding performance.
Bio-Techne is a leading life sciences company that develops and provides innovative products and tools for researchers and clinicians. We are committed to enabling cutting-edge research and improving human health through our products and services.
