Validation Specialist
Insight Global
Job Description
Insight Global is seeking a Validation Specialist to support a large pharmaceutical client. In this role you will test and document the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implement operating procedures. Create documentation to show that a manufacturing or production process has consistent results and meets quality standards. Lead and manage multiple commissioning / qualification / validation activities. Complete GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists, and final handover of documents to Operations with minimal supervision. Complete TrackWise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities. Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
3-5 Years Experience with Validation / CQV Engineering within the pharmaceutical industry
Highly proficient with equipment and process validation (IQ, OQ, PQ)
Experience with CAPAs, deviations and utilizing TrackWise QMS
Bachelor's Degree in Engineering or related discipline Temperature Mapping Experience
Experience with Media Fills, Packaging Equipment Qualification null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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