CQV Validation Engineer

Job Title: Validation Engineer

Location: Thousand Oaks CA

Duration: 12 Months contract

Top 3 Must Have Skill Sets:

Experience in a GMP environment, experience generating C&Q protocols, experience executing C&Q protocols

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.

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.

Basic Qualifications

Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience