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Automation Lead
Automation LeadCatalyx • Indianapolis, IN, us
Automation Lead

Automation Lead

Catalyx • Indianapolis, IN, us
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Job Description

Catalyx is seeking an Automation Lead who will be responsible for the control system solution for an area within a project ensuring the solution is aligned with the overall program automation philosophy, standards and user requirements. The area lead will work in conjunction with the other members of the Project Team, including the Automation Project Manager, Automation Technical Lead, Automation Area Leads, Process Engineers, Tech Services / Manufacturing Science Representatives, Quality Engineers, and Operations.

Role Responsibilities :

  • Technical ownership for an area in a project
  • Define the S88 software structure and list for the area
  • Develop draft function design specifications for the area
  • Work with system integrators to finalize the functional specifications
  • Participate in P&ID and control strategy reviews
  • Working closely with the Project Technical Lead and System Integrator to successfully deliver the project on schedule and budget
  • Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards
  • Ensure consistency of the automation deliverables in the area (requirements, functional specifications, control strategies, phases, and recipes, etc.)
  • Assist in defining the software components that need to be created or modified
  • Communicate progress, issues, and needs to automation technical lead for the project
  • Develop and partner with the selected System Integrator to create computer system validation deliverables (alarm rationalization, system overview, source code reviews, testing, etc.).
  • Secure vendor documents for skidded equipment to integrate with validation deliverables.
  • Responding to system integrator technical queries
  • Identification of any remediation effort required on process control software
  • Create items in the issue tracker as issues arise after the software acceptance

Requirements

  • BS Engineering (or equivalent experience)
  • 8+ years working Automation experience in the Pharmaceutical Industry (preferable in API / bulk manufacturing)
  • Previous Pharmaceutical Automation Large Project / Program experience / expertise
  • 5+ years’ experience in DeltaV Batch DCS
  • Previous experience in Allen-Bradley PLCs
  • Exceptional teamwork abilities
  • Strong knowledge of GMP’s, regulatory requirements and computer system validation principles
  • Excellent written and verbal communication skills for both technical and non-technical audiences
  • Strong knowledge of GMP’s, regulatory requirements and computer system validation principles
  • Excellent written and verbal communication skills for both technical and non-technical audiences
  • Why Join Catalyx?

    At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

    Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

    Requirements

  • BS Engineering (or equivalent experience).
  • 10+ years working Automation experience in the Pharmaceutical Industry (preferably in API / drug substance manufacturing.
  • Previous experience in the delivery of large Automation Projects in the Pharmaceutical Industry.
  • 5+ years’ experience in DeltaV Batch DCS.
  • 3+ years’ experience with Allen-Bradley PLCs.
  • Preferable, previous experience with Aveva PI.
  • Exceptional teamwork abilities.
  • Strong knowledge of GMP’s, regulatory requirements and computer system validation principles.
  • Excellent written and verbal communication skills for both technical and non-technical audiences
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