Education Details: BS or Equivalent
Job Locations: Indianapolis, IN (Remote)
SKILLS:
Proactive mindset.
Natural problem solver.
Skilled in writing protocols and collaboration.
Demonstrated skill with scripting and test automation.
Mentor, guide and support fellow team members.
Drive for innovation and continuous improvement.
Effectively organize and prioritize tasks to make the most of available time.
Key Responsibilities:
Technical ownership for the project Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards Collaborate with their Digital/MES workstream counterpart leads to align the automation and digital solutions Provide technical leadership to the multiple area leads working on their project for the respective area/node and ensure that applicable standards are followed Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies, phases, and recipes, etc.) Participate in P&ID and control strategy reviews Assist in defining the software components that need to be created or modified Communicate progress, issues, and needs to automation project manager for the area Provide input, review, and approve functional requirements and specifications Support creation of Parameter and Recipe Specification documents Responding to system integrator technical queries Support the development of software testing strategies 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: BS Engineering (or equivalent experience) 10+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing) Previous Pharmaceutical Automation Large Project/Program experience/expertise Experience with Delta V DCS Preferable, a 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 Process Automation project experience with the Delta V platform Understanding of Process Automation implementation in a Pharma/Biotech environment. Familiarity with ISA 88 and GAMP Clear understanding of Software Development Life Cycle (SDLC) and Agile methodologies. Bachelor's or Graduate's Degree in engineering, chemical engineering, electrical engineering or computer engineering, or equivalent experience. Experience with SCADA, PLCs, HMI, APIs, SQL software and systems is not required but desirable. 10+ years relevant Delta V experience in pharmaceutical or biopharmaceutical industry
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