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 Validation Cleaning & Process Mgr - New Albany, Ohio, United States

Job information
Posted by: American Regent, Inc. 
Hiring entity type: Other 
Work authorization: Existing work authorization required for United States
Position type: Direct Hire, Full-Time 
Compensation: ******
Benefits: See below
Relocation: Not specified 
Position functions: Other
Travel: Unspecified 
Accept candidates: from anywhere 
Languages: English - Fluent
Minimum education: See below 
Minimum years experience: See below 
Resumes accepted in: English
Cover letter: No cover letter requested
Job code: GW8VB63MNBgWh3yHTBJJPIRSM3nZmM / Latpro-3797219 
Date posted: Jun-06-2021
State, Zip: Ohio, 43054


Validation Cleaning & Process Mgr, (New Albany, OH) American Regent, Inc.: Bachelors' in Life Sci, Eng., or rel. Skills: Supervise technicians or coordinate w/ diff. teams for tracking progress of validation proj's. Generate cost-benefit analyses or ROI assessments used as basis for decision-making on proposed validation proj's or improvements for manuf. processes. Dvlp SOP's rel. to equip. or validation processes. Lead process validation prog. w/ tchncl transfer team. Review qualifications/requalification packages for completeness & accuracy, compliance w/ validation policies or outside reg. policies. Validation of traditional, RABs or isolator tchnlgy manuf. processes pertaining to parenteral pharm. drug products, both aseptic & terminally sterilized. Qualification & review of clean utilities, lyophilizers, terminal sterilizers, autoclaves, depyrogentation tunnels/ovens, vial washers, comp syst's, isolators, & CIP & SIP Syst's. CPV of CQAs or CPPs for the commercial manuf. of parenteral product through control charting. Qualification of analytical lab equip. such as, incubators/freezers/refrigerators, ovens, water baths, liquid chromatography mass spectrometry, centrifuges, UV analyzers, etc. Validation of secondary packaging equip. or automatic inspection machines. Validation of both automated or manual cleaning techniques. Provide tchncl troubleshooting assistance for identifying & addressing manuf. anomalies or deviations. Writing detailed risk assessments rel. to process, cleaning, or equip. validation/verification proj's. Risk analysis activities, to support non-conformances, quality investigations, product impact assessments, product risk evaluations & CAPA investigations. Provide tchncl input, such as address validation deviations, provide assessments for change requests, or identify qualification req'mts to ensure compliance to GMP's & that validated state is maintained. Employer will accept any amount of grad coursework, grad research exp or prof'l exp w/ req'd skills. Must have Six Sigma Certif. To apply, write job code VSAR2021 on resume & email: Resume must ref. job code VSAR2021.
recblid emg21dbp4s53787ledok35454icgib




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