Senior Specialist, Global Engineering Solutions (GES)

MSD•Rahway, NJ

19h•Hybrid

About The Position

The Senior Specialist, Global Engineering Solutions (GES), is based in Rahway, New Jersey, and reports to the Technical Director. The role focuses on process design, execution, and startup for small-molecule high-potency API and containment projects. The initial assignment is to support the execution phase of the MACS project in Rahway. The position may also provide exposure to other business areas, including large-molecule biologics, vaccines, and sterile operations for Human Health and Animal Health. As part of a high-performing team, the Senior Specialist implements capital project scope and technical startup in support of company business objectives. Under the direction of a Process Lead or Technical Director, the role plans, designs, and implements capital projects, collaborating with integrated project team members, engineering firms, and vendors. The position calls for strong leadership, interpersonal, collaboration, communication, and decision-making skills, as well as the ability to guide global work and provide guidance to team members. The individual is expected to understand the line of business, Lean design and delivery, standard work, and end-to-end leadership of technical areas and capital projects. A strong understanding of equipment and facility design, safety practices, standards, operations, maintenance, and industry regulations is also required. This project-based position requires on-site support five days per week, flexibility to travel up to 50%, and flexibility in work location based on project needs. Assignments may involve short-term travel. The listed flexible work arrangement is Hybrid. The role offers an opportunity to contribute to the development of the company’s small-molecule manufacturing network and its US-based small-molecule manufacturing investment portfolio, while working with the Rahway GES team and the broader global GES community. The company describes its employee rewards program as including benefits designed to support employees and their families.

Requirements

Bachelor of Science degree or higher in Chemical Engineering or Mechanical Engineering, or an equivalent applied life sciences qualification.
At least 5 years of experience in a pharmaceutical or biotech industry engineering, technology, and/or manufacturing role.
Knowledge of API manufacturing processes, including reactors, filter dryers, TCUs, and potent isolators.
Knowledge of cleaning methodologies for API, large-molecule, and small-molecule operations.
Knowledge of management of change and process hazard analysis.
Knowledge of potent compound containment, including OEB 4/5.
Knowledge of regulations and industry guidance, including NEC electrical classification.
Knowledge of pressure safety valves (PSVs) and chemical processing.
Experience with an equipment life-cycle approach and capital management stage-gate processes.
Required skills include adaptability, change-control processes, customer orientation, deviation management, engineering standards, GMP, maintenance engineering, manufacturing process validation, process optimization, regulatory compliance, root cause analysis, strategic thinking, teamwork, technical support, and technical transfer.
Strong leadership, interpersonal, collaboration, communication, and decision-making skills; ability to guide global work and provide guidance to team members.
Strong understanding of Lean design and delivery, standard work, equipment and facility design, safety practices, standards, operations, maintenance, and industry regulations.
Ability to lead technical areas and capital projects from an end-to-end perspective.
Ability to work on site five days per week and travel up to 50% based on project needs, including possible short-term travel assignments.

Responsibilities

Interface with integrated project team members to support capital project delivery and provide solutions that meet business objectives.
Lead technical design workshops with end users to develop equipment User Requirement Specifications (URS).
Assess multiple options and select a leading technical approach.
Apply core process knowledge, including unit-operation specification, PFD/P&ID development, hazard analysis, electrical classified design, equipment design and operation, and commissioning and qualification.
Review architect- and engineering-generated PFDs and P&IDs for compliance with corporate standards, operational flexibility needs, and process safety requirements.
Participate as a subject matter expert in PHA, HAZOP, and LOPA sessions and ensure process deviations are addressed in P&ID design.
Serve as the primary commercial and technical interface between the capital project and equipment vendors.
Apply project change-control principles, evaluate design changes for cost, schedule, and safety impacts, and obtain required financial approvals to prevent unapproved scope changes while maintaining design integrity.
Work within project and department cost and schedule constraints.
Lead and collaborate with contractors, suppliers, and team members, ensuring work follows the GES Project Roadmap for capital project execution.
Drive process-equipment design as a Package Owner or Suite Lead in collaboration with engineering firms and equipment suppliers.
Lead Factory Acceptance Testing and commissioning and qualification activities.
Lead peer reviews for assigned packages and participate in peer reviews across multiple projects.
Maintain knowledge of best practices and industry trends and may participate in professional or technical organizations.
Participate in developing and reviewing procedures, practices, engineering guidelines, standards, and other core documents.
Support the execution phase of the MACS project in Rahway as the initial assignment.
Provide on-site project support five days per week and travel up to 50% as project needs require.