What are the responsibilities and job description for the Senior Validation Engineer position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Responsible for development, execution & analysis of validation projects to demonstrate facility cGMP compliance.
- Project includes work with compounding, SIP, CIP, BFS, leak detection, Doboy, labeling, and packaging.
- Author and execute IQ/OQ/PQ Protocols for compounding, sterile filling, and secondary packaging equipment and operations.
- Provide technical assistance to change controls/CAPA's, and deviations.
- Design and execute process and cleaning validation studies meeting site and industry standards.
- Assist with product changeovers, troubleshooting investigations and continuous improvement initiatives.
- Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure and optimization of validation approaches.
Requirements:
- A Bachelor's of science degree in Pharmacy, Engineering or Science is required.
- 3 years of experience in life sciences engineering is required.
- 1 years of experience in validation is required.
- Experience working in FDA/cGMP compliant environment required.
- Strong collaboration, communication, and presentation skills required.
Recommended Skills
- Engineering
- Manufacturing
- Compliance Reports
- Product Quality Assurance
- Operations
- Technical Services
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