Validation Engineer: Drive Process & Cleaning Excellence

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 80,000 - 90,000; Full time

Job summary

Merck & Co. seeks a Process Engineer to plan, execute and direct process/cleaning validation and studies with solid pharmaceutical engineering judgment. You will educate internal partners, monitor projects, and maintain cooperative relationships across departments.

Reporting to the Manager of Technical Services, you will manage post-approval projects, analyze data, and support deviations and audits while coordinating cross-functional teams to ensure timely completion of assignments.

Qualifications

• Bachelor's degree in Pharmaceutical/Biomedical Engineering required.
• Master's degree in Pharmaceutical/Biomedical Engineering preferred.
• 2+ years in Pharmaceutical/Manufacturing industry required.

Responsibilities

• Prepare validation protocols and reports for manufacturing process and cleaning process qualification; execute the qualification/validation/study.
• Coordinate with cross-functional teams to ensure timely completion of projects.
• Analyze statistical data, products or specs to ensure conformance with standards and quality requirements.
• Coordinate/oversee development of new processes or troubleshoot existing ones.
• Assist in deviation investigations to identify root causes and define corrective/preventive actions (CAPA) and assist in audits.
• Initiation of Change Controls and Planned Deviations when required.

Skills

Communication

MS Word

Excel

PowerPoint

MS Project

Education

Bachelor's degree (Pharmaceutical/Biomedical Engineering)

Master's degree (Pharmaceutical/Biomedical Engineering)

Tools

MS Word

Excel

PowerPoint

MS Project

Job description

Merck & Co. seeks a Process Engineer to plan, execute and direct process/cleaning validation and studies with solid pharmaceutical engineering judgment. You will educate internal partners, monitor projects, and maintain cooperative relationships across departments.

Reporting to the Manager of Technical Services, you will manage post-approval projects, analyze data, and support deviations and audits while coordinating cross-functional teams to ensure timely completion of assignments.