Director/Assoc. Director, Automation Engineering

Paragon Bioservices   •  

Harmans, MD

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 80 days ago

This job is no longer available.

Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon’s scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.

The Director/Assoc. Director Automation Engineering will have automation engineers on their team and will report directly to the VP of IT. This role will provide key support for various manufacturing, quality and research systems. This will include Programmable Logic controllers (PLC), PI Data Historian, IGNITION for data reporting & remote alarms, Single Use Bioreactors and Other Equipment Manufacturer (OEM) systems in Manufacturing, QC labs and Research Operations.

This role will be responsible for the automation strategy to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs. This role will drive projects in the deployment of new process and IT capabilities and be responsible for the professional development for their direct reports.

This role will lead automation-related investigations into Atypical Production Reports (APRs) and implement the corrective actions. Initial responsibilities include working with the startup team and providing technical leadership in fulfilling the automation requirements for a new - $40M GMP Manufacturing facility. The Lead Automation Engineer is responsible for partnering with Quality Assurance and
manufacturing leaders in maintaining CGMP requirements. The role provides multiple opportunities to learn new skills in
IT, automation and process analytical technologies and help advance innovative gene therapies to patients.

Must be able to work and be on call off day shifts including weekends.

Key Responsibilities include, but are not limited to:

  • Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.
  • Understands and supports all GMPs, safety, and environmental regulations. Partner with peers in Manufacturing, Quality Control
    and Research areas on continuous improvement Initiatives.
  • Provide coaching and development opportunities for direct reports.
  • On atypical automation situations, develops and supports long term corrective actions.
  • Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems. Oversees investigations of automation anomalies to prevent recurrence.
  • Participates in audits and training programs for automated systems
  • On-floor support of manufacturing activities.
  • Identify and implement process/equipment improvements and manufacturing efficiencies.
  • Maintain technical documentation.
  • Provides client services support for business area applications.

Education & Experience:

  • Bachelor’s degree in Information Technology, Science, or Engineering field required
  • 10 years’ experience in an Automation role supporting GMP equipment required
  • 4 years leading others required
  • Effective leadership, interpersonal and communication skills (written and oral) are required
  • Background in Allen Bradley & Siemens PLC, SCADA, Batch Operations (S88/S95), IT, and single use OEM equipment required
  • Experience in Process Data Analytics preferred.