Automation Systems Engineer, GMP

3 weeks ago

Rapid City, South Dakota, United States GenScriptProBio Full time

Job Title: Automation Systems Engineer, GMP

We are seeking an experienced Automation Systems Engineer, GMP to join our team at GenScript/ProBio.

About the Role:

The Automation Systems Engineer, GMP will be responsible for administration of the Supervisory Control and Data Acquisition (SCADA) system, and management of automation systems installed on the GMP manufacturing equipment and instruments.

This includes the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems.

The incumbent will also understand and support additional GxP systems such as BAS, Maximo, and more.

About the Responsibilities:

  • GMP / GLP Activities
  • SCADA, BAS, Maximo, and other automation engineering Systems Administration
    • Monitoring of system performance and operability
    • Developing Change Controls to enhance systems and operation
    • System Modifications per Change Control
    • Developing Validation Protocols, Reports, and Life-Cycle documents
    • Executing Validation Protocols
  • Automation Systems Management
    • Developing automation for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments
    • Authoring 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)
    • Prioritizing and juggling multiple concurrent projects and day-to-day requests.
    • Liaising with Business, Managed Services, and IT to coordinate the IT Change Request processes
    • Maintaining a 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 & responsibilities.

About the Qualifications:

  • 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

About the Company:

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

It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

About the Salary:

We estimate the salary range for this position to be approximately $120,000 - $150,000 per year, depending on qualifications and experience.

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