Description

Description:

The Associate Process Engineer reports to the Technical Lead or head of Technical Services. Executes Process/Cleaning Validation/Study assignments as per directives. Creates protocols, data collection and analysis and prepare reports under supervision.

Essential Functions:

• Prepare validation protocols & reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study
• Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements
• Prepare and review manufacturing batch record and other engineering qualification documents as required
• Coordinate/oversee the development of new processes or troubleshoot existing ones
• Review Annual Product Review reports and plot trend analysis & APR reports
• Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA)
• Assist in various audits

Additional Responsibilities:

• Performs other functions as required or assigned.
• Complies with all company policies and standards.
• Initiation of Change Controls and Planned Deviations when required
• Reviews manufacturing/ Packaging batch records and Engineering qualification documents
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Education:

• Bachelors Degree (BA/BS) Pharmaceutical/Chemical Engineering - Required
• Master Degree (MS/MA) Pharmaceutical/Chemical Engineering - Preferred

Experience:

• 1 year or more in Pharmaceutical/Manufacturing Industry

Skills:

• Excellent verbal and written communication skills. - Advanced
• Proficiency in MS Word/Excel/Powerpoint. - Advanced
• Multi-tasking. -

Specialized Knowledge:

• Basic Analytical Knowledge desirable.
• 21 CFR, cGMP, basic manufacturing process knowledge.

The salary for this position ranges from $65,000 to $80,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what 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, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. 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. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.