Senior Valiadation Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Madison
Posted on: January 26, 2023

Job Description:

Job Title:- Senior Validation Engineer
Location:- Madison, WI
Duration:- contract
Job Summary:
This position is responsible for development, execution, & analysis of validation projects to demonstrate facility, equipment, and process consistency and cGMP compliance for a sterile fill client. Responsibilities include the generation and execution of IQ/OQ/PQ protocols and summary reports. The selected will also collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches. Other duties include providing validation project management associated with new or modified facilities; acting as interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules.
Job Description:
- 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.
Qualifications:
- 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.

Keywords: Katalyst Healthcares & Life Sciences, Madison , Senior Valiadation Engineer, Engineering , Madison, Wisconsin