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Validation Engineer
Chicago, IL
Job Description
Proclinical is currently recruiting for a Validation Engineer with a pharmaceutical company located in Chicago, IL.
Job Responsibilities
Proclinical Staffing is an equal opportunity employer.
Job Responsibilities
- Support QA oversight of quality standards and systems aligned with the Engineering function in the above areas. They will be experienced in associated regulatory inspections
- Process comparability, PPQ (process, cleaning, filter etc.), Revalidation, CPV (data, statistic, KPI) and Annual Product Reviews (basic knowledge), Process improvements, SOPs review & approval, Deviation (oversight), Changes, Inspections
- Conduct Quality Assurance Oversight activities including issue and Risk Management for local capital investment projects in area of responsibility
- Collaborate with internal partners for the execution of all capital projects
- Delivers a consistent quality approach to facility and process design and development for capital projects
- Provide QA oversight on process within capital project.
- Conduct Quality Assurance Oversight activities including issue and Risk Management, for QbD, technology transfers, and validations
- Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all technology transfers and associated validations
- Supports Quality decisions regarding technical transfers and, validation activities are aligned with the direction of the organization.
- Supports Process Engineering and Sites in improvements projects and provides QA guidance
- Conduct Quality Assurance Oversight activities for Engineering Standards & Engineering Documentation and Knowledge Management in Validation
- Delivers to global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
- Responsible for the approval of the documentation in the above areas, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the entire capital project.
- Bachelor's Degree or higher in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
- 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
Proclinical Staffing is an equal opportunity employer.
Job Summary
Company
Proclinical Staffing
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3+ years
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