Pharma Process Engineer - Validation & CAPA Lead

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Bonuses or performance-based awards

401(k) matching contribution

Diverse health and insurance benefits

Job summary

A leading pharmaceutical company is seeking a Process Engineer to oversee validation protocols and manage post-approval projects. The ideal candidate has at least 2 years of experience in the Pharmaceutical/Manufacturing Industry, holds a Bachelor's Degree in Pharmaceutical/Biomedical Engineering, and possesses strong analytical skills. The role offers a competitive salary ranging from $80,000 to $95,000, along with performance-based incentives and comprehensive health benefits.

Qualifications

• 2 years or more in the Pharmaceutical/Manufacturing Industry.
• Basic analytical knowledge desirable.
• In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.

Responsibilities

• Prepare validation protocols & reports for manufacturing processes and cleaning qualifications.
• Manage post-approval projects; coordinate with cross-functional teams.
• Analyze statistical data for conformance with established quality requirements.
• Oversee development of new processes or troubleshoot existing ones.
• Assist in investigations to identify root causes and define corrective actions.
• Initiate change controls and planned deviations when required.

Skills

Excellent verbal and written communication skills

Proficiency in MS Word/Excel/PowerPoint/Microsoft Project

Education

Bachelor’s Degree in Pharmaceutical/Biomedical Engineering

Master’s Degree in Pharmaceutical/Biomedical Engineering

Job description

A leading pharmaceutical company is seeking a Process Engineer to oversee validation protocols and manage post-approval projects. The ideal candidate has at least 2 years of experience in the Pharmaceutical/Manufacturing Industry, holds a Bachelor's Degree in Pharmaceutical/Biomedical Engineering, and possesses strong analytical skills. The role offers a competitive salary ranging from $80,000 to $95,000, along with performance-based incentives and comprehensive health benefits.