Senior Specialist, Global Engineering Solutions (GES)

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., * 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.

Teamwork Operations Leadership Management Automation Innovation Compassion Stage Gate Peer Review Adaptability Communication Life Sciences Biotechnology Commissioning Animal Health Change Control Process Design Process Safety Pharmaceuticals Decision Making Hazard Analysis Project Scoping Small Molecules Large Molecules Technical Design Telephone Skills Equipment Design Technical Acumen Project Delivery Biopharmaceuticals Project Management Safety Engineering Strategic Thinking Root Cause Analysis Business Objectives Process Engineering Contingent Workforce Process Optimization Chemical Engineering Deviation Management Regulatory Compliance Mechanical Engineering Change Control Process Manufacturing Processes Software Technical Review Internet Protocol Telephony Good Manufacturing Practices Hazard And Operability Study Application Programming Interface (API)

At least 5 years, 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., * Bachelor of Science Degree (or higher) in Chemical or Mechanical Engineering or an equivalent applied life sciences qualification.

Required Experience and Skills:

• 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.

Required Skills: 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

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $117,000.00 - $184,200.00

Why is this a compelling position for a dynamic and ambitious Process Engineering professional to consider?

• Excellent opportunity to play a key role in the future development of Our Company’s Small Molecule network. Our Company is undergoing a period of significant investment in US based small molecule manufacturing, presenting wide ranging opportunity to demonstrate technical acumen, leadership and innovation in delivering the capital portfolio.
• Superb opportunity to join the existing GES team in Rahway and become a part of the broader GES community which presents opportunities to be exposed to the network of sites worldwide while developing and growing your career.
• Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and the people that matter the most in their lives., 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 in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.