Job: Automation Engineer, Locus Biosciences, Morrisville, NC
Morrisville, NC 27560 United States
Research and Development
Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our team as a full-time Automation Engineer. This position is well suited for those that have a strong desire to directly design and extend Locus’ automation capabilities and provides an excellent opportunity for growth into a leadership role as the company expands.
The primary responsibility for the position is the development and maintenance of our synthetic biological automation platform and systems equipment. An ideal candidate will have extensive coding and software engineering experience that complements a core skillset in automation technologies. A background in Mechanical or Software Engineering complemented by experience in general microbiology and molecular biology would be preferred. The Automation Engineer will also be responsible for maintaining, troubleshooting, and modifying the GMP and non-GMP control systems. Systems include plant wide HVAC control, BMS, 3rd party local control systems, freezers, air handlers and chillers.
This individual must be able to communicate effectively in formal and informal settings and be able to work well within a team.
Responsibilities will include:
• Implement automation efforts across the Company, including development, validation and maintenance of our core automation platforms
• Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS) and draft systems design documents, including mechanical CAD, electrical CAD, and software repository maintenance
• Development and execution of CSV (computer systems validation) across all the company platforms
• Good working knowledge and implementation of GAMP 5 and ISPE Good Automation Practices is a must
• Identification of new equipment, processes or other optimized workflows to support expansion of platform capabilities
• Retrospective documentation and validation as needed to provide a good forward maintenance path
• Lead development, and optimization of internally developed high-throughput, automated methods that drive our microbiology, synthetic biology and molecular biology efforts
• Maintenance of automation equipment, including responsibility for all reactive and proactive maintenance work, on-site and on-demand response to equipment breakdowns
• Management of GMP software porting from one operating system to the next
• Develop software and code to support our bioinformatics team
• Develop and maintain systems and data repositories that meet the needs of high-throughput data acquisition and analysis generated from the automation platform
• Determine equipment or system specifications and most cost-effective technology to be implemented. Prepare scopes of work and manage automation contractors as required to complete required work within project timelines
• Implementation of compliance initiatives including monitoring of system security procedures and practices, review of audit trails and system logins for conformance and assessment of cumulative change impact.
• Execute automation and controls for capital investments at the site, as well as develop site procedures for documentation of automation control systems, from specifications through operational procedures.
Job Type: Full-time
Job Location: Research Triangle Park, North Carolina
For immediate consideration, please email your resume or CV to: firstname.lastname@example.org
Direct applicants only. No agencies please.
• Minimum B.S. degree in Engineering, Computer Science or related technical field
• A minimum of 8-10 years of experience in biotech or pharmaceutical industry including experience in bacteriophage or bacterial cell culture, recovery, purification, aseptic fill/finish.
• Ideal candidate will have hands-on experience in coding and configuration of control and data acquisition systems, IT infrastructures, automated calibration and maintenance management systems
• Experience in designing and implementing PLC, Data Management or networked automated systems
• Familiarization with object-oriented programming tools, R, Python, C/C++ and RDBMS
• Demonstrated experience in project management to timelines and budgets is a requirement.
• A minimum of 2 years’ experience in utilizing and troubleshooting laboratory automation instrumentation (advanced liquid handlers/dispensers and plate readers), including protocol development and optimization.
• Working knowledge of the Hamilton Microlab STAR platform a bonus
• Ability to structure, implement and maintain study plans in the face of evolving projects and programs
• Willingness to develop solutions to difficult objectives independently and consistently
• Must be highly motivated and can work independently as well as part of an interdisciplinary team with diverse backgrounds
• Have hands-on experience with engineering design, commissioning and validation. Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
• In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
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