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Biologics Technical Lead

Xyntek Incorporated, a CXV Global Company
Lebanon, IN Full Time
POSTED ON 1/25/2025
AVAILABLE BEFORE 4/19/2025

Job Description

Biologics Technical Lead

Purpose of the Role :

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 deliver the project on schedule successfully 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 work stream 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

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 audience
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