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.  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.   

Candidate will participate in a range of activities including, but are not limited to: 

Primary Responsibilities: 

• 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, SOP’s, 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.    

Education Minimum Requirement:  

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

Required Experience and Skills:  

• Highly motivated with the ability to work in a fast-paced and dynamic setting.   

• Significant experience in multiple BPP automation technologies: Ignition, DeltaV, Rockwell PLC, PI, PI Asset Framework, OPC interfaces, Unicorn, Firewall Rulls, 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 

Desired Experience and Skills:  

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. 

PRD 

Required Skills:

Preferred Skills:

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