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Senior Automation Engineer, Clinical Manufacturing

AbCellera Biologics

AbCellera Biologics

Software Engineering
Vancouver, BC, Canada
Posted on Friday, October 28, 2022

AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 450 AbCellerites and growing, we’re expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.

You will be a key member of the clinical manufacturing team responsible for the design, construction, commissioning, qualification, validation, and operation of a new GMP manufacturing facility for the production of antibody therapeutics. The facility will produce API for global clinical studies and will be based around 2x2000 L single use bioreactors. You will be a key member of the manufacturing team at AbCellera responsible for delivering on a critical strategic program that will have a long-lasting legacy on the organization and Canada.

This role will be responsible for defining the automation strategy for the new single use clinical manufacturing facility. You will provide automation and instrumentation and control engineering capabilities and expertise to the various functions including generating qualification protocols and maintaining the validated state of systems and processes. You will focus on support for the clinical manufacturing facility with respect to the automation and instrumentation and control systems for process, utility and building systems and provide technical input to automation impacting projects.

We’d love to hear from you if

  • You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
  • You are passionate about building dynamic new teams and capabilities that accomplish important goals
  • You have a bias towards innovation over industry standards
  • You are enthusiastic about applying your expertise in advancing information technology within manufacturing operations
  • You are an outstanding communicator and teammate

How you might spend your days

  • Being responsible for active oversight of the automation design and commissioning process
  • Working with IT to deliver integrated solutions across multiple platforms
  • Defining and managing processes for automation commissioning including Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
  • Generating, executing and reviewing Installation, Operational, and Performance Qualification protocols
  • Generating, reviewing and approving GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.)
  • Partnering with key stakeholders to define system requirements and functional specifications
  • Performing automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement
  • Providing automation impact assessments for process and equipment changes
  • Producing and reviewing design drawings and specification documents (URS, FS, DS, etc.)
  • Initiating, executing and tracking progress of change records
  • Supporting the start-up and troubleshooting of automation and critical process utility systems
  • Supporting the plant that operates 24x7 to assess discrepant events and changes for automation impact, delivering automation solutions to resolve operational issues, assisting in troubleshooting and providing real time on floor support of manufacturing operations, and participating in site coordination meetings
  • Supporting Deviation Management, CAPA, and Change Control activities, as required
  • Serving as Automation SME to Quality, Manufacturing, and other Functions. Support manufacturing investigations, including OOSs, OOTs, RCAs, etc
  • Evaluating and recommending automation upgrades to existing equipment or systems
  • Reviewing and/or drafting Equipment Drawings, Electrical Diagrams, System Manuals, Engineering Protocols and Reports, Validation Documentation, and other Quality System Documentation
  • Maintaining critical relationships with control system & unit operation vendors for lifecycle updates & maintenance
  • Supporting the operational rollout of new technologies as they are deployed to development, clinical and commercial sites
  • Contributing in global IT/OT alignment & coordination initiatives, particularly process automation, tech transfer activities, technology selection & documentation standards
  • Developing departmental procedures for documentation of automated systems, from specifications through operational procedures

Required skills and experience

  • BS in engineering, computer science or equivalent engineering discipline
  • 8+ years of automation system experience, and 5+ years relevant biopharmaceutical industry experience
  • Experience with cGMP/GMP, data integrity, computer system validation, safety principles, and working within a regulated industry
  • Experience with biopharmaceutical manufacturing, cell culture
  • Experience with defining class-based modules
  • Experience configuring and testing phase logic and sequence flow charts
  • Experience with control and equipment modules, state driven algorithms
  • Experience configuring and testing communication protocols including OPC UA, Ethernet IP, Modbus TCP and Profibus
  • Experience with Biopharmaceutical manufacturing, design or/and construction
  • Knowledge of process, utility and building control systems
  • Knowledge of GMP guidelines, experience in generation of controlled documents
  • Qualification experience related to control and computer systems
  • Ability to generate engineering drawings and specifications
  • Knowledge of ISA standards, PID control theories and techniques
  • Knowledge of PLC (programmable logic controllers), and associated programming languages (RSLogix Preferred)
  • Excellent written, verbal, and presentation skills
  • Ability to work with users to clearly define written requirements
  • Adaptability to rapidly changing priorities and deadlines

What we offer

We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!

About AbCellera

At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.

We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. We’re looking for someone like you to support and organize our efforts along the way.