Automation Administrator

Location: Remote is possible. Northeast US

Duration: 12-18 months (possibility of extensions)

Start Date: November

As an Automation Systems Administrator, you will be embedded in a tight-knit team responsible for administration of automated/computerized system software and firmware to meet cGMP and procedural requirements. Our team specifies software configuration for biopharmaceutical process, monitoring, and testing systems. In this critical role we evaluate new software for functional equivalence to existing software. We author test plans to demonstrate suitability of software. A significant focus of this role is supporting the authoring and maintenance of configuration specifications for cGMP automated and computerized systems in our quality control and/or manufacturing process areas.

  • Ensuring data is backed up or archived to ensure systems can meet defined RTO (Recovery Time Objective) and RPO (Recovery Point Objective).
  • Utilizing configuration management and recipe/method management
  • Creating and maintaining configuration specifications for process control, monitoring and testing
  • Supporting system SAT (Site Acceptance Testing) / FAT (Factory Acceptance Testing), validation and qualification efforts
  • Reviewing system lifecycle design documentation
  • Ensuring systems remain in a compliant state by processing change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation, and quality risk assessments
  • Conducting system integration with existing systems (e.g. LIMS, Historian)
  • Drafting, approving, and following relevant system software SOPs and policies
  • Providing end-user support including solving problems at the application level and hardware troubleshooting (includes working with vendors to resolve issues) and training them on system functionality
  • Initiating, authoring, and reviewing documents such as Change Controls, investigations, deviations, risk assessments, impact statements, and corrective/preventative action plans.
  • Participating in, leading, or authoring investigations and root cause analysis for department issues of non-compliance
  • Administering user access including control access to software systems; adding, modifying, and removing users; defining user types, user groups, and security settings
  • Leading aspects of the work of automation contractors and providing guidance as applicable

This role might be for you if you:

  • Thrive in manufacturing, lab, or other regulated IT environment
  • Have a solid grasp of System Design Lifecycle and Quality Risk Management
  • Understand manufacturing process/supporting laboratory testing and/or regulatory requirements, related terminology and jargon commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation
  • Enjoy crafting sustainable solutions to sophisticated issues
  • Understand process control systems and product release testing systems
  • Are familiar with regulatory and quality policies, procedures and documentation methods, ideally in cGMP biotech/pharma operations
  • Enjoy working independently as part of a broader team with a proven focus on customer service
  • Enjoy project management and have stellar organizational skills
  • Have a knack for compiling documentation

Applicants ideally should have a BS/BA in Science, Engineering or related field and the following minimum relevant experience for each level:

  • Associate Automation Systems Administrator: 0+ years
  • Automation Systems Administrator: 2+ years
  • Senior Automation Systems Administrator: 5+ years
  • Principal Automation Systems Administrator: 8+ years

Industries: Pharmaceutical
Employment Type: Contract
Skills: Automation Computer Software Validation
Location: Remote

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