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Manufacturing Equipment Validation Specialist/Engineer
2 months ago
About the Role
At Roche, we're committed to pushing the boundaries of healthcare innovation. As a key member of our team, you'll play a vital role in ensuring the quality and reliability of our manufacturing processes.
Key Responsibilities
- Develop and execute qualification and validation strategies for equipment, facilities, and utilities in our biotech manufacturing plant.
- Collaborate with cross-functional teams to plan and conduct qualification and validation activities, ensuring timely completion and adherence to regulatory requirements.
- Author and execute qualification protocols, and document results accurately and in accordance with established procedures.
- Provide technical expertise and guidance to junior staff, and serve as a resource for other departments, including Manufacturing, Operations, Quality, and Regulatory Affairs.
- Participate in the transfer of products and technologies, and provide scientific knowledge and assistance to support business objectives.
Requirements and Qualifications
- Strong technical expertise in equipment validation and qualification.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Knowledge of regulatory requirements and industry standards.
