Project Automation Area Lead

Validation and Engineering Group, Inc

$100K — $130K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • BS in Engineering or equivalent experience
  • 8+ years in Automation, specifically within the Pharmaceutical Industry
  • Experience managing Large Pharmaceutical Automation Projects/Programs
  • 5+ years of experience with DeltaV Batch DCS
  • Familiarity with Allen-Bradley PLCs
  • Strong teamwork skills
  • Knowledge of GMPs, regulatory requirements, and computer system validation principles
  • Excellent communication skills for technical and non-technical audiences

Responsibilities

  • Assume technical ownership for a specific area within a project
  • Define the S88 software structure and component list for the area
  • Draft functional design specifications for the designated area
  • Collaborate with system integrators to finalize functional specifications
  • Engage in P&ID and control strategy reviews
  • Work alongside the Project Technical Lead to ensure timely project delivery
  • Align automation solutions with overall program philosophy and standards
  • Ensure consistency across automation deliverables such as requirements and control strategies
  • Develop Parameter and Recipe Specification documents
  • Address queries from system integrators and identify remediation needs for process control software
  • Track and document issues post-software acceptance
  • Evaluate and plan responses for technical risks associated with the area
  • Maintain compliance with training requirements

Benefits

  • Hybrid work environment with some remote flexibility
  • Travel opportunities to Indiana once a month based on project needs
  • Collaborative work with a variety of technical specialists and project teams
  • Opportunity to lead and impact large-scale pharmaceutical projects
  • Access to professional development and training to stay current in automation standards
Full Job Description
  • Project Automation Area Lead

This is a hybrid opportunity and can be based anywhere in the United States, but will require travel to Indiana a minimum of 1 week a month based on project needs.

Purpose of the Role:

The Automation Area Lead will be responsible 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
  • Provide input, review, and approve functional requirements and specifications
  • Develop Parameter and Recipe Specification documents
  • 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
  • Identify and analyze risks of technical nature particular to the area and planning responses
  • Maintain compliance with training requirements

Role Requirement:
  • BS Engineering (or equivalent experience)
  • 8+ years working Automation experience in the Pharmaceutical Industry
  • Previous Pharmaceutical Automation Large Project/Program experience/expertise
  • 5+ years' experience in DeltaV Batch DCS
  • Experience with 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

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