Automation Project Lead

Job 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.)
• Aid 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
• Respond to system integrator technical queries
• Create items in the issue tracker as issues arise after the software acceptance
• Analyze risks of technical nature particular to the area and plan responses

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
• Preferrably previous experience with Allen-Bradley PLCs
• Strong knowledge of GMP’s, regulatory requirements and computer system validation principles
• 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