Associate Director, Biologics Pilot Plant Automation

Job Description

Applications are being sought for an associate director position in our Research and Development Division Biologics Pilot Plant (BPP) automation engineering group. The individual will utilize technical expertise to lead and perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

• Provide expertise in multiple automation platforms utilized in the BPP
• Provide technical training and mentoring within the automation group and cross‑functional
• Work with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant’s reliability and increase efficiencies
• Author and review GMP change controls, test protocols, SDLC documentation, SOPs, safety reviews, deviation investigations and actions
• Lead ongoing automation system support and troubleshooting in the facility
• Lead the design, scope, implementation, and GMP close out of pilot plant projects including the specification and automation integration of new equipment, upgrades and improvements
• Provide automation leadership for GMP clinical manufacturing campaigns in the facility
• Cross‑train in many areas and technologies
• Actively work in a multi‑discipline cross‑functional project team environment

In addition to the core responsibilities outlined above, an opportunity exists to collaborate across our Research and Development Division and our Manufacturing Division with automation and data initiatives. Some off‑shift (second shift and weekends) will be required to support campaigns.

Bachelor’s degree in engineering with a minimum of 7 years of relevant manufacturing automation experience.

• Highly motivated with the ability to work in a fast‑paced and dynamic setting
• Significant experience in multiple BPP automation technologies:
  Ignition, Delta
  
  V, Rockwell PLC, PI, PI Asset Framework, OPC interfaces, Unicorn, Firewall rules, IT/OT technologies and software
• Demonstrated ability to train individuals and influence functional groups
• Previous automation experience supporting GMP production of pharmaceuticals, biopharmaceuticals, or vaccines. This includes executing GMP change controls, System Development Life Cycle (SDLC) documentation, and data integrity principles
• Strong project management, organizational, communication and leadership skills
• Ability to work independently and in a team environment

Experience with manufacturing equipment, process control, automation infrastructure design, and/or cybersecurity. Experience with integrating equipment automation systems with Enterprise IT managed systems, e.g. MES, virtualization, networking, windows and antivirus patching/updates. Experience with Project Management Methodologies (Agile, Waterfall, etc.) and Tools (MS Project, RACI, GANTT). Experience with building and planning technology road maps. Experience with biologics manufacturing equipment (bioreactors, filtration skids, chromatography skids).

Experience supporting GMP audits.

Current Employees: apply here.

Current Contingent Workers: apply here.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.

Effective September 5, 2023, employees in office‑based positions…