Automation Engineer

GMP
Full Time, Contract Corp-To-Corp, Contract Independent, Contract W2, C2H Corp-To-Corp, C2H Independent, 6 months++
open
Telecommuting not available Travel not required

Job Description

Automation Engineer - Pharmaceutical/Biotech
Company is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing Client technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. 
The Automation Engineer will be part of a team reporting to the VP of IT and 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 trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs. This role will have the opportunity to lead projects in the deployment of new process and IT capabilities. 
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. For various project assignments/initiatives, the Automation Engineer is responsible for partnering with Quality Assurance and Manufacturing groups 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 in rotation with 3 other engineers.
Key Responsibilities include, but are not limited to: 

  • Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.
  • On atypical automation situations, develops and supports corrective actions.
  • 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.
  • 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:
Required:

  • Bachelor degree in Information Technology, Science, Engineering or related field.
  • Minimum of 3 years experience in an Automation role supporting GMP manufacturing
  • Effective leadership, interpersonal and communication skills (written and oral) are required.

Desired:

  • A working knowledge of the regulatory requirements for pharmaceutical applications is desirable.
  • Highly desired are skills in PLCs, SCADA, Batch Operations (S88/S95), IT, and OEM equipment.
  • Experience in Process Data Analytics is desired

 

Posted By

Debra Spressart

Dice Id : 10108966
Position Id : 657978
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