Sr. Spclst, Engineering

Merck•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Applications are sought for a senior specialist position in our Research & Development Division's Biologics Pilot Plant (BPP) automation engineering group. The 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. The candidate will participate in a range of activities including technically leading ongoing automation system support, providing automation expertise for GMP clinical manufacturing campaigns, leading and/or executing the design, scope, implementation, and GMP close out of pilot plant projects, authoring and reviewing GMP change controls, test protocols, SDLC documentation, SOP’s, safety reviews, deviation investigations and actions, leading ongoing maintenance and upgrade projects for automation systems, working with the team to innovate and evaluate new technologies and automation systems to improve reliability and increase efficiency, and cross-training in various areas and technologies. The role involves actively working in a multi-discipline cross-functional project team environment. Additionally, there is an opportunity to collaborate across the 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.

Requirements

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

Nice To Haves

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)

Responsibilities

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
Collaborate across our Research & Development Division with automation and digital initiatives
Contribute towards defining/streamlining various business processes for efficient and flexible GMP clinical supply for products in all phases of development