Sr. Spclst, Engineering

Job Description

Applications are sought for a senior specialist position in our Research & Development Division's Biologics Pilot Plant (BPP) automation engineering group.  Individual will 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:

• Technically lead ongoing automation system support in the facility

• Provide automation expertise for GMP clinical manufacturing campaigns in the facility

• Lead and/or execute the design, scope, implementation, and GMP close out of pilot plant projects including the specification and automation integration of new equipment, upgrades and improvements

• Author and review GMP change controls, test protocols, SDLC documentation, SOP’s, safety reviews, deviation investigations and actions

• Lead ongoing maintenance and upgrade projects for automation systems in the facility

• Work with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant’s reliability and increase efficiency

• 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 & Development Division with automation and digital initiatives and to contribute towards defining/streamlining various business processes for efficient and flexible GMP clinical supply for products in all phases of development. Some off shift (second shift and weekends) will be required to support campaigns.  

Education Minimum Requirement:

Bachelor’s degree in engineering or computer science with a minimum of 5 years of relevant automation experience.

Required Experience and Skills:

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

• Strong organizational, planning, and communication skills.

• Previous automation experience supporting GMP production of pharmaceuticals, biopharmaceuticals, or vaccines.  This includes executing GMP change controls.

• Significant experience in one or more of the following automation technologies:  DeltaV, Ignition, PLC/SCADA.

• 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 (Jira/Confluence, RACI, GANTT)

Required Skills:

Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

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US and Puerto Rico Residents Only:

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