Senior Automation Engineer, GMP

7 days ago

Rapid City, South Dakota, United States GenScriptProBio Full time
Job Summary

We are seeking a highly skilled Senior Automation Engineer to join our team at GenScript/ProBio. As a key member of our automation group, you will be responsible for the administration of our Supervisory Control and Data Acquisition (SCADA) system, as well as the management of automation systems installed on our GMP manufacturing equipment and instruments.

Your primary focus will be on the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems. You will also be expected to understand and support additional GxP systems such as BAS, Maximo, and more.

You will work closely with internal departments, including Manufacturing, Facilities & Engineering, and Quality Assurance, as well as external resources to maintain our SCADA, BAS, Maximo, and other GMP manufacturing systems. You will ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Key Responsibilities
  • Perform GMP/GLP activities
  • SCADA, BAS, Maximo, and other automation engineering systems administration
    • Monitoring of system performance and operability
    • Developing appropriate change controls to enhance systems and operation
    • System modifications per change control
    • Developing appropriate validation protocols, reports, and life-cycle documents
    • Execution of validation protocols
  • Automation systems management
    • Developing appropriate automation for bioprocess equipment, including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments
    • Authoring appropriate change controls and test scripts and serving as Manufacturing's subject matter expert for applicable changes
    • Recommending and integrating new bioprocess equipment and Process Analytical Technologies (PAT)
    • Ability to prioritize and juggle multiple concurrent projects and day-to-day requests
    • Liaison with Business, Managed Services, and IT to coordinate the IT change request processes
    • Maintaining current knowledge base of solutions and working with Managed Services sustainment teams to facilitate technical break/fixes
  • Knowledge of domestic/international regulatory guidelines/compendia (FDA, ICH, USP, and EMEA guidelines) for validation of equipment and systems
  • Knowledge of applicable cGMP/GLP requirements, procedures, methods, and protocols for performance of assigned duties and responsibilities
  • Training
    • cGMP training
    • Applicable corporate and departmental directives, policies, and procedures
    • Good manufacturing practices and good documentation practices
    • QA quality general
    • Hopewell biologics manufacturing general/all
    • HBM automation control and data acquisition
    • Engineering EHS training
    • Lab/biological safety EHS training
    • Hopewell biologics manufacturing gowning

Requirements:

  • Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least ten years of related experience that provides direct scientific knowledge of system automation validation principles and biologics production equipment/systems
  • Direct knowledge of the biologics process equipment, SCADA/control systems, and validation practices
  • Expertise in scientific/technical subject areas – equipment qualification, computer system validation, cleaning validation, SCADA system architecture, biotech process equipment/systems
  • Proficient in use of electronic systems – Microsoft Office, various specialized software including process documentation Veeva Vault, material management (SAP), computerized maintenance management system (Maximo), building automation system (BAS)
  • Expertise in Rockwell Automation (Allen Bradley) programming software and Wonderware SCADA systems
  • Familiarity with OSI Pi a plus
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

GenScript/ProBio is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.

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