Senior Specialist, Global Engineering Solutions (GES)

Merck; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck in Rahway, NJ is seeking a Senior Specialist in Process Design, Execution and Startup for Small Molecule HPAPI containment projects. You will lead capital project design, ensure safety and regulatory compliance, and collaborate with IPT, Engineering Firms, and Vendors to deliver end-to-end solutions.

The role emphasizes technical startup, commissioning, and qualification, with travel up to 50% and on-site support in Rahway.

Qualifications

• Minimum 5 years in pharmaceutical/biotech engineering or manufacturing.
• Strong knowledge of API manufacturing processes and potent compound containment.
• Experience with hazard analysis, process safety, and cGMP.

Responsibilities

• Interface with IPT members in support of capital project delivery.
• Lead technical design workshops with End Users to develop Equipment URS.
• Assess multiple options and select a leading approach.
• Core knowledge should include unit operations, PFD/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 and safety needs.
• Participate in PHA/HAZOP/LOPA sessions, ensuring process deviations are addressed in the P&ID design.
• Act as the primary interface between capital projects and Equipment Vendors.
• Adhere to Project Change Control principles to prevent scope creep while maintaining design integrity.
• Familiarity with API operations, chemical handling, process safety, and HPAPI containment controls.
• Lead and collaborate with contractors, suppliers and team members in the execution of the work.
• Drive design of process equipment as Package Owner or Suite Lead; collaborate with Engineering Firms and Vendors.
• Lead Factory Acceptance Testing, Commissioning and Qualification activities.
• Lead peer reviews for assigned Packages and participate across projects.
• Maintain knowledge of best practices and industry trends; participate in professional organizations.
• Participate in development and review of core documents such as procedures and standards.

Skills

Pharma/Biotech experience

Process Design

Containment/HPAPI

GMP Compliance

Cross-functional Leadership

Change Control

Technical Transfer

Project Coordination

Education

Bachelor of Science in Chemical Engineering

Job description

Role Summary

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.

Job Description

Role Summary

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.

Primary 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.

Percent of Travel

Position is project-based, requiring on-site support 5 days per week. Flexibility with travel up to 50% and work location is also required based on project need; assignments may require short term travel assignments.

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.

Education Minimum Requirement

• 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

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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