Automation Engineer/Controls Engineer - GMP , Pharma

Alcami Corporation-posted 9 months ago
Full-time • Mid Level
North Charleston, SC
Chemical Manufacturing
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At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. The Automation Engineer is accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects. The Automation Engineer's primary responsibilities will center around evaluating and implementing new ways to automate systems that drive efficiency and compliance, testing automation equipment and processes, programming new automated components, evaluating existing auto-generated reports for improvement, and maintaining current automation systems.

  • Designs and/or implements manufacturing technology to automate production processes and equipment.
  • Supports production operations from an equipment and process troubleshooting standpoint.
  • Implements production efficiency improvements.
  • Develops user and design requirements for automation projects.
  • Selects equipment vendors or completes technology design and equipment build in-house.
  • Manages the installation of automation while ensuring safety.
  • Supports the validation of the automated system for adherence to requirements, CGMPs, and intended system operation.
  • Supports Maintenance Technicians in troubleshooting situations.
  • Interacts with production supervisors/managers to identify areas for improvement.
  • Implements automation solutions resulting from deviations, investigations, and/or CAPA assignments.
  • Composes Functional Requirement Specifications (FRSs) for new or upgraded systems.
  • Designs and/or implements modifications to existing manufacturing equipment.
  • Acts as engineering and technical lead for key plant projects.
  • Provides technical support for safety and quality improvement initiatives.
  • Programs PLCs, HMIs, SCADA systems, and inspection systems.
  • Manages multiple capital projects concurrently.
  • Generates and revises standard operating procedures.
  • Leads Manufacturing Deviation investigations.
  • Implements corrective and preventative actions.
  • Performs risk assessment and risk mitigation activities.
  • Participates in internal discussions for project execution.
  • Requests bids from contractors and suppliers.
  • Formalizes CAPEX document preparation and submission.
  • Maintains company reputation by complying with regulations.
  • Maintains a safe, clean, and organized work environment.
  • Ensures compliance with cGMP and training requirements.
  • Bachelor's degree in engineering or related field required.
  • Minimum 4 years' experience in Automation / Controls Engineering.
  • Previous work experience in a sterile manufacturing environment preferred.
  • Experience with robotics, AI, and machine learning.
  • Experience with project management.
  • Prior pharmaceutical/industry GMP experience required.
  • Mastery of a variety of automation software applications.
  • Proficiency with Microsoft Office applications.
  • Solid understanding of computer programming and software development.
  • Ability to troubleshoot equipment and perform complex system tests.
  • Exemplary knowledge of discrete machine control.
  • Mastery of Data Historian.
  • Strong leadership and problem-solving skills.
  • Strong analytical skills.
  • Ability to keep up with the latest technologies.
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