Validation Engineer Senior, California

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.
" Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
" Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
" Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
" Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
" Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
" Other duties may be assigned to this role.

Key Skills and Requirements:
" Educated to a degree level in a technical or natural scientific field.
" Demonstrable experience in a pharma organization within a C&Q/CQV corresponding role.
" Knowledge of qualification needs to cGMP guidelines.
" Familiarity with Kneat Gx Platform or other digital C&Q systems.
" Familiarity working with cross-department stakeholders.
" Knowledge of quality assurance principles.
" Experience working within project teams and various projects in parallel.
" Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
" Effective communication skills, both verbally and in writing.
" Able to think analytically with the ability to resolve issues.
" Able to manage own time efficiently.

Position could be extended to up to 3 years