| 15+ exp || Local || Principal Commissioning-Validation Engineer III (Engineering) || 18+ months || Waltham, MA at Waltham, Massachusetts, USA |
| Email: [email protected] |
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From: Aditya Mishra, Anveta [email protected] Reply to: [email protected] Principal Commissioning/Validation Engineer III (Engineering) - LOCATION: Waltham, MA - Duration: 18 Months - (2) years with (6) month extensions based on performance!! PLEASE READ the Job Description and Highlighted skill sets. Thank you! MUST HAVE; Global/Digital CS System QAV Representation and deliverables approver. QAV Documentation Review and Approvals for local and CMOs. CS Periodic Reviews planning and approvals experience QA GMP IT Support for DI and CS INF activities The manager has had challenges with previous recruitment. The candidate must be: 1. Local and 100% onsite- (Can relo on own) 2. Camera should be ON during interview (2 interviews) 3. Sr. Level resource only 4. Extension is needed after 6 Months but will extend beyond based on performance. * Must Have: Minimum Education BSc/BEng degree in Engineering or related field * Previous Pharma Experience required * Previous QA Validation Experience Required with a Minimum 10-15 years of experience. * Previous experience supporting a Business System Owners on their GMP Manufacturing and Lab Equipment as well as supporting Corporate/Global Computerized Systems and manufacturing. * Previous experience QAV department in drafting, reviewing, approving documentation Description: *** Fully Onsite * *** References will be required !! Past mngers email & phone # or NO interview! Responsibilities will include: Local Validation Program Maintenance QAV Documentation Review and Approvals for local and CMOs. CS Periodic Reviews planning and approvals QA GMP IT Support for DI and CS INF activities Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation) QRFR's Generation Metrology Deliverables Review & Approval (forms or SOPs) + SAP Operation SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. Validated Equipment Requalification, Modification/ Remediation/ Decommissioning Software Upgrade(s) Validation SME support for QMS Impact Assessments and Change Actions Validation Support for Risk Assessment on Equipment AdHOC Validation Support on Global Computerized Equipment Deployment. Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Sanofi standards and GMP regulations. The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Sanofi guidelines. URS Registration/ Calibration form SCCA forms Risk Assessment (for equipment with CSV) Configuration Spec. (for equipment with CSV or as applicable) Vendor qualification package (if purchased) Global/Digital CS System QAV Representation and deliverables approver. Internal Validation protocol Requirements Traceability Matrix Internal Final Report. Reports will be provided within client Quality Management System and email. Reports to channel through Quality Assurance Validation staff. Minimum requirements: Engineer or related BSc/BEng degree Previous Pharma Experience required Previous QA Validation experience Required Minimum 10-15 years of experience Previous experience supporting a Business System Owners on their GMP Manufacturing and Lab Equipment as well as supporting Corporate/Global Computerized Systems and manufacturing. Previous experience QAV department in drafting, reviewing, approving documentation Thanks & Regards Aditya Mishra Us IT Recruiter Linkedin- https://www.linkedin.com/in/aditya-mishra-59466823b/ Email: [email protected] | 4694980325 Ext 408 |URL: http://www.anveta.com Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA ANVETA, Inc Keywords: quality analyst information technology Massachusetts Texas 15+ exp || Local || Principal Commissioning-Validation Engineer III (Engineering) || 18+ months || Waltham, MA [email protected] |
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| 02:39 AM 04-Dec-24 |