• Posted on: Jun 22, 2022
  • Location: Frederick, MD
  • Job ID: 413bcf28
  • Type: Full Time
  • Posted on: Jun 22, 2022
  • Location: Frederick, MD
  • Job ID: 413bcf28
  • Type: Full Time

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A biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.  Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.  We are on a rapid growth trajectory and have a highly energized and accomplished team.

 

We are seeking a highly motivated individual to join us as a Senior Automation Engineer/ Site Data Historian Program Lead.  You will be responsible for overseeing a core Site Data Historian program that will be deployed throughout the manufacturing network.  This program is an integral component in both the manufacturing technology stack as well as the corporate informatics program.  The solutions will provide for flexible, innovative, cost effective, compliant and quality-focused environment.

 

 

Responsibilities

  • Oversee the Site Data Historian scope of the program which will include:
    • Historian application, standards, templates, life cycle management
    • Data collection interfaces and configuration for common equipment and systems
    • GMP and non GMP reporting and visualization
    • Information accessibility to data analytics platforms
  • Implement new use-case based capability enhancements to the platform
  • Automation Projects and CapEx: Developing, planning and implementing automation-based projects and solutions in collaboration with cross-functional teams, including determination and delivery on cost, time and quality to ensure the sustained production, successful product launches and customer satisfaction
  • Projects may be new facilities and/or retrofit of existing
  • Support the validation of automation systems with QA Validation
  • Provide leadership and/or technical support to projects in support of the Capital Plan
  • Provide advanced technical expertise
  • Provide advanced historian and data analytics technical knowledge for troubleshooting, investigations and training
  • Provide advanced interface and VM support including installation
  • Provide advanced system design for data integrity, stability and interface between different systems. Ensure effective maintenance and availability of historian applications.
  • Optimization and compliance: Responsible for technical optimization of the historian systems
  • Creation, modification, and maintenance of global historian system and documentation, including automation specification documents and SOPs, in a compliant state
  • Contributes to, support, and leads BPE/MPE activities to ensure a continuous optimization process
  • Global Engineering Network for automation and standardization
  • Support definition and implementation of best practice of historian technical standards and procedures
  • Participate in peer reviews

 

 

Basic Qualifications

 

Advanced scientific degree (i.e. MD, PharmD, PhD)

OR

Master’s Degree and 6+ years of historian applications, engineering, installation and management experience

OR

Bachelor’s Degree and 8+ years of historian applications, engineering, installation and management experience

OR

High School Degree and 12+ years of historian applications, engineering, installation and management experience

 

Preferred Qualifications

  • 10+ years in historian applications, engineering, installation and management
  • 5+ years in biotech or pharma industry
  • BS/BA
  • Expertise in OSI PI Historian systems
  • GMP environment experience
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