Sr. Specialist, Compliance/Engineering – Oral Solid Dosage (Onsite)

Job Summary

Merck is seeking a Sr. Specialist, Compliance/Engineering – Oral Solid Dosage to work onsite at our FLEx Center in Rahway, Union County, New Jersey. This senior engineering role provides critical compliance and technical support for non‑sterile oral solid dosage equipment and utilities across clinical, development and commercial programs.

Key Responsibilities

• Provide engineering expertise and regulatory compliance guidance for all non‑sterile OSD process equipment and utility systems.
• Lead root‑cause investigations, risk assessments, and CAPA activities for equipment deviations and validation gaps.
• Develop, review, and maintain design specifications, qualification protocols (IQ/OQ/PQ) and standard operating procedures.
• Collaborate with cross‑functional teams – R&D, Manufacturing, Quality, Validation and Health‑Safety – to ensure seamless technology transfer and scale‑up.
• Support equipment qualification, performance qualification, and ongoing preventive maintenance programs.
• Act as the technical liaison with external vendors and contract manufacturers, overseeing installation, qualification and compliance documentation.
• Maintain up‑to‑date knowledge of FDA, EMA, USP and GMP requirements related to oral solid dosage manufacturing.
• Prepare and present technical reports, audit findings and compliance status updates to senior leadership.

Required Qualifications

• Bachelor’s degree in Chemical, Pharmaceutical, Mechanical Engineering or related field; Master’s preferred.
• Minimum 5 years of experience in pharmaceutical engineering, preferably with oral solid dosage manufacturing.
• Strong understanding of cGMP, FDA 21 CFR Part 210/211, ICH Q7, USP  and related regulatory standards.
• Proven experience with equipment qualification, validation, and compliance documentation.
• Excellent problem‑solving skills, data‑driven decision making and ability to work independently.
• Effective communication and teamwork abilities; experience presenting technical information to diverse audiences.

Preferred Skills

• Experience with Process Analytical Technology (PAT) and continuous manufacturing concepts.
• Knowledge of risk‑based approaches such as FMEA and HACCP.
• Familiarity with SAP or other ERP manufacturing modules.

Compensation

Salary range: $117,412.71 – $117,412.71 per year.

Location

Onsite – Rahway, Union County, New Jersey, United States.

Frequently Asked Questions

What type of products will I support in this role?

You will support non‑sterile oral solid dosage (tablet and capsule) products throughout clinical, development and commercial manufacturing.

Do I need a specific engineering license?

A professional engineering license is not required, but a bachelor’s degree in engineering or a related science and relevant pharmaceutical experience are mandatory.

Is this position fully onsite?

Yes, the role is based onsite at Merck’s FLEx Center in Rahway, Union County, New Jersey.