Senior Engineer I, Validation

Are you a highly skilled engineer with a passion for ensuring product quality and compliance? Look no further than Catalent, a global leader in providing integrated services and solutions to the pharmaceutical, biotechnology, and consumer health industries. We are seeking a Senior Engineer I, Validation to join our dynamic team and play a crucial role in validating our manufacturing processes and equipment. As a Senior Engineer I, you will have the opportunity to utilize your extensive knowledge and expertise to ensure our products meet the highest standards of quality and regulatory compliance. If you thrive in a fast-paced, collaborative environment and possess the necessary qualifications, we encourage you to apply for this exciting opportunity.

1. Develop and implement validation strategies and plans for manufacturing processes and equipment.
2. Conduct risk assessments and identify critical process parameters to ensure product quality and compliance.
3. Design and execute validation protocols, including IQ, OQ, and PQ, to verify equipment and processes meet required specifications.
4. Analyze validation data and provide recommendations for process improvements and corrective actions.
5. Collaborate with cross-functional teams to ensure validation activities are completed on time and in accordance with regulatory requirements.
6. Review and approve validation documents, including protocols, reports, and standard operating procedures.
7. Stay current with industry best practices and regulatory requirements related to validation.
8. Support regulatory inspections and audits by providing validation documentation and participating in audits as needed.
9. Train and mentor junior engineers and technicians on validation procedures and protocols.
10. Participate in new product introductions and technology transfer projects by providing validation support and expertise.
11. Identify and implement continuous improvement initiatives to enhance the validation process.
12. Communicate effectively with internal and external stakeholders regarding validation activities and findings.

According to JobzMall, the average salary range for a Senior Engineer I, Validation in Madison, WI, USA is between $89,000 and $120,000 per year. However, this can vary depending on factors such as years of experience, specific industry, and company size.

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.