Associate Director, Biologics Pilot Plant Automation

Merck•Upper Gwynedd Township, PA

5d•Hybrid

About The Position

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:

Requirements

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

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 (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.

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