Oscar Jauregui Email & Phone Number

New York, Ny, Us

New York, Ny, Us

Woodcliff Lake, New Jersey, Us

South San Francisco, California, Us

Continuation of Validation Engineer I responsibilities with larger workload.

South San Francisco, California, Us

- Member of the “Complex Projects and Utilities” team and responsible for qualification projects and issues, with emphasis on utilities systems.- Lead the re-qualification of seven air handlers and 52 associated cleanrooms after air handler re-balance while minimizing impact on production.- Qualification lead on project to install a new Purified Water System using Paperless Validation System.- Own and coordinate Change Record to update 22 documents for use with new paperless validation system (eVALRoche). - Author and approve test plans, qualification protocols/reports, System Impact Assessments, Criticality Assessments, and other technical reports. - Assess change records and discrepancies for impact to validated state of equipment.- Act as Air Handler qualification expert and mentor others.- Investigate, resolve, and write validation deviations; including root cause analysis, impact assessment and corrective actions.- Act as representative in cross-functional team to determine site and departmental impact due to regulatory requirement changes..

South San Francisco, California, Us

Contract Through Naderi Engineering, Inc- Use TrackWise and Aspen InfoPlus.21 to perform periodic reviews of equipment by assessing change records and monitoring data for validation impact. - Research and write test plans, qualification reports, criticality assessments, gap remediations, and other technical reports. - Coordinate equipment cleaning verification and revalidation by creating sampling plans and sample request forms, communicating with operations, and compiling final reports and data packages.- Assess change records for impact to validated state.- Investigate, resolve, and write validation deviations; including root cause analysis, impact assessment and corrective actions.

Raritan, New Jersey, Us

Contract Through Experis Engineering- Write cleaning validation protocols to provide clear, concise information and instruction on the validation of cleaning procedures according to strict cGMP standards.- Coordinate with production technicians and supervisors across all 3 shifts to schedule protocol execution around the constantly changing production schedule.- Train technicians and oversee protocol execution in order to ensure smooth completion.- Swab equipment in order to test for absence of product residue and microbial bioburden and prove effectiveness of the cleaning procedure.- Audit executed protocols and get necessary clarifications from technicians in order to achieve accuracy and clarity.- Analyze data and write comprehensive reports to prove cleaning effectiveness and validate cleaning procedures.- Conduct investigations and determine appropriate corrective actions for cleaning validation related discrepancies.- Perform periodic reviews of process equipment validation status by reviewing change records through TrackWise and procedure change history.

Raritan, New Jersey, Us

Contract Through Kelly Services- Work with team in cGMP facility to manufacture medicine in efficient and safe manner.- Designated as process Subject Matter Expert during external audit of facility by international drug regulations agency.- Work in dynamic environment and quickly adjust to changing priorities to efficiently meet schedule attainment.- Train and develop team to become proficient in process to ensure high quality and zero downtime for customers in receiving materials. - Communicate with planner and personnel of over 15 different process rooms and familiarize myself with their schedules in order to build my own team’s schedule.- When problem arises, determine appropriate response in order to effectively resolve issue.- Maintain cleanliness by cleaning process room and equipment to cGMP standards.