Demo

Technical Lead

Intellectt INC
Indianapolis, IN Full Time
POSTED ON 2/2/2025
AVAILABLE BEFORE 5/2/2025

The Biologics Technical Lead will be responsible for technically leading the Automation control system solution for the Biologics facility. They will work closely and in conjunction with the other members of the Biologics facility Project Team, including the Automation Project Manager, the Automation Area Leads, Process Engineers, Tech Services / Manufacturing Science Representatives, Quality Engineers, and Operations.

Role Responsibilities :

Technical ownership for the Biologics project

Technical management of the Biologics project system integrator

Working closely with the Biologics Automation Project Manager 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

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 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

Role Requirement :

BS Engineering (or equivalent experience)

10 years working Automation experience in the Pharmaceutical Industry (preferable in API / bulk

manufacturing)

Previous Biologics Manufacturing project or site experience

Previous Pharmaceutical Automation Large Project / Program experience / expertise

7 years' experience in DeltaV Batch 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

Strong knowledge of GMP's, regulatory requirements and computer system validation principles

Excellent written and verbal communication skills for both technical and non-technical audienc

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