Senior GMP Systems Engineer
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.
Lyell is building a state-of-the-art immunotherapy manufacturing facility utilizing advanced system automation and data integration to enable the production and delivery of our cell therapy to cancer patients. We are looking for an experienced and forward-thinking engineer to join our GMP Systems and Data Management team. You will be responsible for implementing and owning the automation and data for instruments and equipment to support manufacturing and quality control operations. This role will also provide system oversight and day to day support to Technical Operations to ensure priorities are being addressed in a timely manner to meet Lyell’s clinical programs timeline.
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.
KNOWLEDGE, SKILLS AND ABILITIES:
- 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.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.