Process Validation & Cleaning Engineer

Essential Functions

• Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysis, and prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
• Managing the post approval projects.
• Coordinating with cross-functional teams and ensuring the timely completion of projects.
• Analyzing statistical data, products or functional specifications to determine conformance with standards and established quality requirements.
• Cooking/overseeing the development of new processes or troubleshooting existing ones.
• Aiding in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) and assisting in various audits.

Additional Responsibilities

• Initiation of Change Controls and Planned Deviations when required.

Qualifications

• Education: Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required, Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred.
• Experience: 2 years or more in Pharmaceutical/Manufacturing Industry.

Skills

• Excellent verbal and written communication skills - Advanced
• Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced
• Specialized Knowledge: Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.

Pay

The base salary for this position ranges from $80,000 to $90,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.

Benefits

We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.