Automation

AMTSOL•Indianapolis, IN

About The Position

Advanced Manufacturing Tech Solutions (AMTSOL) delivers innovation through technology for Life Sciences Manufacturing, driving Pharma 4.0 and Digitalization to help regulated manufacturers accelerate speed to market, ensure GxP compliance, and enhance operational efficiency. With a strong presence across Singapore, Europe, India, and the USA, AMTSOL specializes in end-to-end implementation and support of GMP manufacturing systems and solutions, spanning Automation, Manufacturing Execution Systems (MES), IT/OT Networking, and Digital Technologies.

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
Preferable, previous experience with Allen-Bradley PLCs
Exceptional teamwork abilities
Strong knowledge of GMPs, regulatory requirements and computer system validation principles
Excellent written and verbal communication skills for both technical and non-technical audiences
Strong knowledge of GMPs, regulatory requirements and computer system validation principles
Excellent written and verbal communication skills for both technical and non-technical audiences

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