Senior Specialist, Global Engineering Solutions (GES)

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

Job summary

Merck & Co. in Rahway, New Jersey, seeks a Senior Specialist to lead process design, execution and startup for Small Molecule High Potency/API/Containment projects. The role focuses on capital project delivery within GES and exposure to multiple business areas, including potential Large Molecule initiatives.

The initial assignment involves supporting the MACS project in Rahway, with travel up to 50% and strong emphasis on safety, cost, and schedule performance across diverse vendor interfaces.

Qualifications

• BS in Chemical or Mechanical Engineering or equivalent.
• Minimum 5 years in pharmaceutical/biotech engineering, technology, or manufacturing.
• Experience with API manufacturing processes and potent containment (OEB 4/5).

Responsibilities

• Interface with IPT members to support capital project delivery.
• Lead technical design workshops to develop Equipment URS.
• Develop PFDs and P&IDs, perform hazard analyses.
• Participate in PHA/HAZOP/LOPA sessions to address deviations.
• Interface with vendors and manage changes per Change Control.
• Lead Factory Acceptance Testing, commissioning and qualification activities.

Skills

Interface with IPT members

Lead design workshops

URS development

PFD/P&ID development

HAZOP/LOPA participation

Equipment design & operation

Commissioning & qualification

Project Change Control

API operations knowledge

Cost & schedule awareness

Contractor & vendor liaison

Education

Bachelor of Science in Chemical or Mechanical Engineering

Job description

Job Description

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.

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.

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:

EEOC Know Your Rights

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

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 the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

50%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/29/2026

A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R422452