Automation Engineer/Controls Engineer - GMP , Pharma

 

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.

 

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Job Summary

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 drives efficiency and compliance.
• Testing automation equipment and processes (driving FAT, SAT, and commissioning activities within the Engineering Department and aiding the Validation Department with qualification efforts).
• Programming new automated components (i.e. door interlock systems, etc.).
• Evaluating existing auto-generated reports for improvement and provide requirements for future auto-generated reports.
• Maintain current automation systems to ensure all software is current and running on the appropriate platform.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Designs and/or implements manufacturing technology to automate production processes and equipment and supports production operations from an equipment and process troubleshooting standpoint as well as implement production efficiency improvements. Automation Engineers are expected to hold both a project management and production support workload.
  • Project Management: Engineering responsibilities include developing user and design requirements, selecting equipment vendors or completing the technology design and equipment build in-house, managing the installation of automation while ensuring safety, and supporting the validation of the automated system for adherence to requirements, CGMPs, and intended system operation.
  • Production Support: Support Maintenance Technicians in situations where troubleshooting or technology may fall outside of their area of expertise. Interact with production supervisors/managers to identify areas to improve equipment throughput, flexibility, quality, safety, and/or reliability. Implement automation solutions resulting from deviations, investigations and/or CAPA assignments.
• Composes Functional Requirement Specifications (FRSs) for new or upgraded utilities systems, compounding processes, and filling equipment.
• Designs and/or implements modifications to the existing manufacturing equipment that will improve the operational efficiencies.
• Acts as engineering and technical lead for key plant projects.
• Provides technical support for and leads safety and quality improvement initiatives.
• Programs PLCs, HMIs, SCADA systems, and inspection systems.
• Manages multiple capital projects concurrently.
• Designs, installs, and supports the validation of the automated control system for new or upgraded utilities systems, compounding processes, and filling equipment.
• Generates and revises standard operating procedures.
• Leads Manufacturing Deviation investigations and applies good engineering practices to reduce the risk of repeat Non-Conformances.
• Implements corrective and preventative actions to improve manufacturing’s operational efficiencies.
• Performs risk assessment and risk mitigation activities using systematic tools.
• Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones.
• Requests bids from contractors and suppliers by working with procurement group, recommends best provider.  
• Formalizes CAPEX document preparation and submission.
• Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• 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. 

Knowledge, Skills, and Abilities

• Mastery of a variety of automation software applications. Software