Senior Specialist, Global Engineering Solutions (GES)

MSD•Rahway, NJ

2d•$117,000 - $184,200•Hybrid

About The Position

The Senior Specialist, based at our Rahway, New Jersey site, reports to the Technical Director with focus on Process Design, Execution and Startup for Small Molecule High Potency/API/Containment Projects. With a large volume and variety of capital project work in GES, this position will also afford future opportunities to be exposed to multiple business areas. This may include Large Molecule Biologics/Vaccines/Sterile both for Human Health and Animal Health. The initial assignment for this role will be to support the execution phase of the MACS project in Rahway. The Senior Specialist will participate on a high performing team responsible for implementation of capital project scope and technical startup that support our company's business objectives. Under the direction of a Process Lead or Technical Director, the Senior Specialist will be responsible for planning, design, and implementation of capital projects. The individual collaborates with Integrated Project Team members (e.g. Operations, Project Management, Technology, Maintenance, Automation and Safety), Engineering Firms and Vendors to progress deliverables. The Senior Specialist will exhibit strong leadership, interpersonal, collaboration and communication skills, decision making, the ability to guide global work, and provides guidance to team members. The candidate should have a strong understanding of the line of business, understand Lean design and delivery, have the ability to implement standard work, and be able to lead technical areas and capital projects from an end to end perspective. The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance, and industry regulations.

Requirements

Minimum 5 years Pharmaceutical/Biotech industry in engineering, technology, and/or manufacturing role.
Core knowledge should include: API Manufacturing Processes (Reactors, Filter Dryers, TCUs, Potent Isolators), Cleaning Methodologies (API/LM/SM), Management of Change, Process Hazard Analysis, Potent Compound Containment (OEB 4/5), Regulations/Industry Guidance (NEC Electrical Classification), PSV’s, and Chemical Processing.
Experience with equipment life cycle approach and Capital Management stage gate process.
Adaptability
Change Control Processes
Customer-Oriented
Deviation Management
Engineering Standards
Good Manufacturing Practices (GMP)
Maintenance Engineering
Manufacturing Process Validation
Process Optimization
Regulatory Compliance
Root Cause Analysis (RCA)
Strategic Thinking
Teamwork
Technical Support
Technical Transfer

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

Interface with our company's IPT members in support of capital project delivery, providing solutions that meet business objectives.
Lead technical design workshops with End Users to develop Equipment URS.
Ability to assess multiple options and select a leading approach.
Core knowledge should include specification of unit operations, PFD/P&ID development, Hazard Analysis, electrical classified design, equipment design and operation, commissioning & qualification.
Perform technical reviews of the A&E-generated PFDs and P&IDs to ensure they meet corporate standards, operational flexibility needs, and process safety requirements.
Participate and provide Subject Matter Expertise in PHA/HAZOP/LOPA sessions, ensuring all process deviations are adequately addressed in the P&ID design.
Act as the primary commercial and technical interface between the capital project and the Equipment Vendors
Adhere to Project Change Control principles, ensuring all design changes are evaluated for cost, schedule, and safety impacts before securing necessary financial approvals to prevent unapproved scope creep while maintaining design integrity.
Familiarity with API operations, chemical handling, process safety, and HPAPI containment engineering controls.
Operating within cost and schedule constraints of the project and department.
Lead and collaborate with contractors, suppliers and other team members in the execution of the work, ensuring adherence to the GES Project Roadmap for capital project execution.
Drive design of process equipment as a Package Owner or Suite Lead, including collaboration with Engineering Firms and Equipment Suppliers.
Lead Factory Acceptance Testing, and Commissioning and Qualification activities.
Lead peer reviews for assigned Packages and active participation in peer reviews across multiple projects.
Maintain knowledge of best practices and industry trends; may participate in professional/technical organizations.
Participate in the development and review of core documents such as procedures, practices, engineering guidelines, standards, etc.