Minimum 1 week a month in Indiana during the basic/detailed design phase of the project. Full time on site during the Commissioning phase of the project.

Constructing multiple standalone, highly flexible GMP clinical trial drug substance facilities on a greenfield site, which also includes site infrastructure, utilities, administrative offices, laboratories, and warehousing. The Clinical Trial facilities on the site will produce drug substances for small molecules, biologics, and nucleic acid therapies. The overall project is in the Basic Engineering design phase.

 Purpose of the Role:

The Automation Area Lead 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

•                    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

Requirements

Role Requirement:

•                    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

•                    Preferable, previous 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

•                    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