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CQV Validation Engineer
Job
ACL Digital
Thousand Oaks, CA (In Person)
Full-Time
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Job Description
CQV Validation Engineer at ACL Digital CQV Validation Engineer at ACL Digital in Newbury Park, California Posted in 2 days ago.
Type:
full-timeJob Description:
Job Title:
CQV Validation Engineer Location:
Thousand Oaks CA Duration:
12 Months contractONLY USC/GC/EAD-NO C2C
Top 3Must Have Skill Sets:
Experience in a GMP environment, experience generating C&Q protocols, experience executing C&Q protocolsResponsibilities:
- 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.