Senior Valiadation Engineer
Company: Katalyst Healthcares & Life Sciences
Posted on: January 26, 2023
Job Title:- Senior Validation Engineer
Location:- Madison, WI
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.
- 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
- 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.
- A Bachelor's of science degree in Pharmacy, Engineering or
Science is required.
- 3+ years of experience in life sciences engineering is
- 1+ years of experience in validation is required.
- Experience working in FDA/cGMP compliant environment
- Strong collaboration, communication, and presentation skills
Keywords: Katalyst Healthcares & Life Sciences, Madison , Senior Valiadation Engineer, Engineering , Madison, Wisconsin
Didn't find what you're looking for? Search again!