Validation Engineer, California

Responsibilities:

Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.

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.

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.