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Validation Engineer
Job Description
Target PR Range: 40-50/hr
*Depending on experience
Description:
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.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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