Specialist, Analytical Instrument Validation

Job Summary

Merck is hiring a Specialist, Analytical Instrument Validation for its Research Laboratories Division in Rahway, Union County, New Jersey, US. This full‑time role offers a fixed annual salary of $137,300.53 and focuses on ensuring analytical instruments meet stringent validation and compliance standards.

Key Responsibilities

• Lead the qualification, validation, and performance qualification (IQ/OQ/PQ) of analytical instruments used in pharmaceutical research.
• Develop, review, and maintain validation protocols, reports, and Standard Operating Procedures (SOPs) in accordance with GMP, FDA, and ICH guidelines.
• Collaborate with cross‑functional teams—including R&D, Quality Assurance, and Manufacturing—to integrate validation activities into project timelines.
• Identify and troubleshoot instrument performance issues, recommending corrective and preventive actions (CAPA).
• Maintain comprehensive documentation and ensure audit‑ready records for internal and external inspections.
• Provide training and mentorship to junior staff on validation best practices and regulatory expectations.

Required Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline; Master’s preferred.
• 5+ years of experience in analytical instrument validation within a regulated pharmaceutical or biotech environment.
• Strong knowledge of USP, FDA, EMA, and ICH validation guidelines.
• Hands‑on experience with HPLC, UHPLC, GC, MS, FTIR, NMR, and other typical analytical platforms.
• Proficiency in data integrity principles, electronic lab notebooks, and LIMS.
• Excellent written and verbal communication skills; ability to present complex technical information clearly.

What We Offer

• Competitive salary of $137,300.53 per year.
• Comprehensive health, dental, and vision benefits.
• Retirement savings plan with company match.
• Opportunities for continuous learning, professional development, and career growth within a global life‑science leader.

How to Apply

Submit your resume and a cover letter highlighting your validation experience through the Merck careers portal. Applications are accepted until the position is filled.

Frequently Asked Questions

What does an Analytical Instrument Validation Specialist do at Merck?

The specialist leads qualification and validation activities for analytical equipment, ensures compliance with regulatory standards, documents results, and supports cross‑functional teams.

What qualifications are required for this role?

A bachelor’s degree in a relevant science, 5+ years of validation experience in pharma or biotech, and strong knowledge of GMP, FDA, and ICH guidelines.

Is the salary fixed for this position?

Yes, the role offers a fixed annual salary of $137,300.53.