Automation Engineering Manager

2 weeks ago


Wilson, North Carolina, United States J&J Family of Companies Full time
Job Title: Automation Engineering Manager

We are seeking an experienced Automation Engineering Manager to join our team at J&J Family of Companies. The successful candidate will be responsible for leading the development and implementation of automation systems, ensuring compliance with global standards and industry best practices.

Key Responsibilities:

  • Develop and implement automation systems, including configuration of interfaces and validation protocols.
  • Ensure compliance with global standards, including cGMP regulations and industry best practices.
  • Lead the CSV team to deliver on key projects and lifecycle management.
  • Define Computerized Systems Validation scope and ensure resources, capabilities, and processes are in place.
  • Collaborate with Quality, IT, Lab Systems, and Procurement teams to optimize processes.

Requirements:

  • BS degree in Engineering, Science, or related discipline.
  • Minimum of 6 years of experience in a manufacturing environment, preferably in the biopharmaceutical or pharmaceutical industry.
  • Proven experience in an Execution Systems, Automation, or IT role within a pharmaceutical or GMP-regulated manufacturing environment.
  • Expertise in ISA S95 and S88 standards and their application within the Global Supply Chain.
  • Knowledge of cGMP regulations related to Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11.

Preferred Qualifications:

  • Experience in supervision/management of people and resources.
  • Process knowledge for Upstream, Downstream, and Bio Processing Support functions.
  • Proven understanding of GAMP 5 and other recognized industry standard methodologies.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.


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