| Pharma Quality Engineer - Thousand Oaks, CA - Locals only at Thousand Oaks, California, USA |
| Email: [email protected] |
| From: Prashanth, AcuBahn Inc. [email protected] Reply to: [email protected] Role: Pharma Quality Engineer Location: Thousand Oaks, CA Must be local no relocation Automation Engineer for Facilities / Utilities / Systems / Equipment (FUSE) and Automation systems related project-based role. As a member of the Capital Project Team, the successful candidate will be required to: Support complex and challenging system implementation, commissioning, and qualification activities that require solid understanding of analytical problem-solving techniques, and operational excellence. Have good understanding of CIP system design, installation, commissioning, and qualification, validation of manufacturing process systems with relation to CIP implementation, validation of CIP cleaning cycles, process controls, automation, and field instrumentation technologies. Have good understanding of design, installation, commissioning and qualification, and validation of manufacturing process systems, process controls, automation, and field instrumentation technologies. Lead and support commissioning and qualification activities of automated CIP Skid, which is to be integrated with building DeltaV control system. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Lead project implementation, commissioning, and qualification activities for automated CIP Skid and its process control applications utilizing Emerson DeltaV DCS, Human Machine Interfaces (HMI), FactoryTalk Supervisory Control and Data Acquisition systems (SCADA), OSI PI database, and RtReports by exception. Have working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Have five (5) or more years combined experience in C&Q of the following: Clean utilities (APR, PUR, WFI) Clean manufacturing equipment DeltaV Distributed Control System OSI PI System, RtReports - Report by Exception Be familiar with industry standards for CIP systems, clean utilities, batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Have experience managing a team of up to five (5) personnel resources supporting project Commissioning and Qualification activities. Ensure that all persons who perform commissioning and project activities have trained on the applicable Company procedures and that the Training verification forms are archived in a GMP system. Have commissioning and qualification experience using Application Lifecycle Management (ALM) procedures. Develop the Commissioning & Qualification Plan (CQP). Lead the commissioning and testing strategy for documentation in CQP Review and approve the requirements, specifications, design implementation and acceptance criteria, as applicable. Coordinate and supervise all Commissioning and Qualification activities. Review and approve all C&Q Test Protocols ensuring that all requirements and acceptance criteria are satisfied. Requirements: 5+ years of experience in Pharma and GxP Rockwell Hanson equipment/plant utilities experience Experience in Change control review and revision contributions CQP generation QRAES Report Generation Reviews of SPEC docs (probably 4) Review and guidance of protocols (about 10) Execution management and coordination over 6-8 weeks Management of multiple C&Q workfolows Discrepancy resolution CQSR/VSR Generation and maintenance C&Q Planning, coordination, and management Centrifuge Equipment CQV with Delta V integrated controls All deliverables can be leveraged from deliverables generated for the B23 Harvest Centrifuge project (C01605), so significant efficiency already gained. Preferred: Familiarity with Veeva and Kneat Keywords: California |
| [email protected] View all |
| Fri Jul 14 18:46:00 UTC 2023 |