Senior Validation Engineer

Summary

Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities.

Responsibilities

• Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
• Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
• Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified GMP analytical and process equipment, utilities, and facilities.
• Execute IQ, OQ, FT, P...