Deviation & Compliance Engineer (Materials)

Merck & Co.; West Point (PA); Hybrid; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks an Incoming Materials Technical Operations Specialist for the West Point, PA site to support deviation management in a GMP environment.

You will author investigations, coordinate CAPAs, and help maintain compliance while driving continuous improvement and on-site project execution. The role requires 2+ years in a regulated setting, strong writing skills, and the ability to work cross-functionally with Operations, Quality, and external vendors.

Qualifications

• B.S. or B.A. in Engineering, Sciences, or related discipline.
• Minimum two (2) years post-bachelor's degree experience in a regulated environment.
• Experience in deviation management / project support and/or change control and/or bio-pharm equipment and/or equipment/process validation.

Responsibilities

• Authors incident and investigation reports for deviations.
• Coordinates and completes CAPAs.
• Authors and reviews Incident Trend Reports.
• Supports deviation reduction efforts.
• Leads continuous improvement projects that increase compliance, reduce cost, and standardize processes.
• Provides on-the-floor support for project implementation and studies.
• Leads or participates in Quality Risk Assessments.
• Supports regulatory inspections/audits.

Skills

Adaptability

Business Writing

Root Cause Analysis

Project Management

Regulatory Compliance

Change Control Management

Deviations Investigations

Scheduling

Teamwork

Technical Writing

Education

B.S. or B.A. in Engineering, Sciences, or related discipline

Job description

Merck & Co., Inc. seeks an Incoming Materials Technical Operations Specialist for the West Point, PA site to support deviation management in a GMP environment.

You will author investigations, coordinate CAPAs, and help maintain compliance while driving continuous improvement and on-site project execution. The role requires 2+ years in a regulated setting, strong writing skills, and the ability to work cross-functionally with Operations, Quality, and external vendors.