What are the responsibilities and job description for the Validation Engineer Senior (CQV - Pharmaceutical) position at Aditi Consulting?
Payrate: $60.00 - $62.00/hr.
Responsibilities:
Pay Transparency: The typical base pay for this role across the U.S. is: $60.00 - $62.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
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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.
- 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 your own time efficiently.
Pay Transparency: The typical base pay for this role across the U.S. is: $60.00 - $62.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Salary : $60 - $62
