Lead Automation Engineer-Delta V

Location: Indiana-Indianapolis, IN - Remote

Employment Type: Full-Time

Job Summary:

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