The successful candidate will have deep experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise developing, implementing, validating, supporting and troubleshooting manufacturing and quality control equipment and instrumentation.
KEY ROLE AND RESPONSIBILITIES:
- Automation and data management for MFG/QC software, equipment and instruments
- Develop strategy for transfer, retention and backup of data for manufacturing and quality control equipment and instrumentation.
- Coordinate a cross functional team, including Manufacturing, QC, Facility and IT, to address new software, equipment and instrument introductions as well as vendor validation efforts (installation and operational qualifications).
- Implement system integrations to eliminate manual data exchanges currently controlled through procedures. Examples include material and equipment statuses.
- Support validation strategy for the automation systems supporting the equipment and instrumentation. Validation strategy considers guidelines from GAMP5, 21CFR part 11 and EU Annex 11.
- Work with other GMP system specialists and IT to ensure alignment with overall Lyell System Roadmap
- Manufacturing Shop Floor and GMP system support
- Provide support, as needed, for Lyell’s GMP systems, including CMMS, EMS, ERP, MES and LIMS.
- Be on call and identify failure points of GMP system issues and contact required supporting teams such as IT/IS or Vendors.
- Configure/update automation systems to support new clinical programs and change requests
- Support GMP system’s software updates
- Coordinate the draft, review, approval and revisions of standard operating procedures, including Automation system administration and Process Development/Technical Transfer documentation.
- Support manufacturing and quality control peripherals such as workstations, printers and barcode scanners.
- Key role in Lyell Paperless initiatives
- Interface directly with Lyell’s IT/IS organization to define key data elements and how these elements will be historized and interfaced with Lyell’s Datalake.
- Support as needed Lyell GxP systems implementation to facilitate the IND filing.
- Bachelor Degree or higher in engineering fields.
- Minimum of 8 years of GMP manufacturing and operations experience with emphasis on equipment and instrument automation and data.
- 5 years of experience with GMP systems and their overall data strategy which support manufacturing and quality control.
- Strong understanding of electronic signatures and records, data integrity, 21 CFR part 11 and EU Annex 11.
- Deep expertise in Process Equipment and Process Automation Systems. Ability to build interfaces for the plant equipment.
- Deep understanding of plant operations including manufacturing and quality control.
- Minimum of 3 years of experience in cell therapy or biologics manufacturing unit operations such as cell processing, aseptic processing, fill/finish strongly preferred.
- Excellent communication, technical writing, and project management skills.
- Demonstrated problem solving capability.
- Highly collaborative and bias for action.
- Understanding of how instrument data can be interfaced (OPC, Webservices, FTP, etc).
- Experience with designing and implementing a Datalake solution.
- Demonstrated experience implementing software systems and performing tasks in a regulated or pharmaceutical production environment..
- Thorough understanding of Master Data, ability to define and manage master data working with a cross-functional team from Manufacturing, Quality, Engineering, and Supply Chain.
- Understanding of ERP, LIMS, data historian, and other common manufacturing-related IT Systems and integration requirements with MES systems is highly preferred.