Senior Specialist, Engineering

MSD•De Soto, KS

1d•Hybrid

About The Position

Global Engineering Solutions (GES) is responsible for the design, construction, and delivery of advanced manufacturing facilities and laboratories worldwide, providing premier engineering solutions in the pharmaceutical industry. This role supports the Animal Health Division, which is investing $895 million in expanding its manufacturing and research & development facilities in De Soto, Kansas. The Senior Specialist operates under the guidance of the GES Process Lead and is part of a high-performing team accountable for the implementation of this major project. The individual collaborates with other Integrated Project Team (IPT) members (e.g., Project Management, Technology, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. The core work includes equip/scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, technology transfer, construction support, equipment qualification, facility start-up and process demonstrations. The role may involve supervising junior engineers and collaboration with resources from an engineering firm. This position will function as the technical/engineering process engineer with prior experience supporting Biologics, Vaccine and/or Sterile Projects.

Requirements

B.S. degree in Engineering (Chemical or Mechanical) or Science is required.
Minimum five (5) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design, Capital Project implementation, Technical Operations, or Operations/EMU.
3+ years experience leading cross functional teams in the startup and C&Q execution of capital projects.
Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification.
Understanding of unit operations specific to vaccine/biologic manufacturing, including hygienic design and aseptic requirements for Buffer Prep, Formulation, and CIP/SIP and experience with primary and secondary packaging operations.
Experience with capital projects that followed a stage gate capital management process.
Excellent collaboration and engagement as a team player with dependable interpersonal and communication skills.
Analytical and problem-solving skills.
Multitasking/time management skills which deliver on time and quality work.
Core knowledge should include specification of unit operations, P&ID reviews, Hazard Analysis, equipment operation, commissioning & qualification execution.
Work independently and meet timelines in a fast-paced team-based environment.
Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude.
Adaptability
Capital Projects
Change Control Processes
Collaborative Communications
Construction
Customer-Oriented
Engineering Standards
Equipment Commissioning
Equipment Specifications
Global Engineering
Good Manufacturing Practices (GMP)
Knowledge Transfer
Maintenance Engineering
Manufacturing Process Validation
Multitasking
Process Optimization
Project Implementations
Project Management
Self Motivation
Strategic Thinking
Teamwork
Technical Support
Technical Transfer
Working Independently

Nice To Haves

An advanced degree in Engineering, Science, or Business is preferred.
Experience with engineering design, equipment operation, startup, and troubleshooting, and C&Q activities.
Proven aptitude for leading project design endeavors and offering creative solutions that align with business objectives.
Previous managerial experience in a similar position.

Responsibilities

Exhibiting strong technical/engineering leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.
Leading a cross functional suite team of 5-10 members through the stage gates of a project and setting them up for success with knowledge transfer.
Ensuring deliverables conform to our standards and practices; and are technically sound.
Providing technical guidance during project implementation, assures viability of technology to meet design intent.
Collaborating with other technical functions to ensure successful technology transfers of new and in-line products.