Associate Process Engineer

Amneal

3d • $65,000 - $75,000

About The Position

Description Description: The Validation 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.

Requirements

• Bachelors Degree (BA/BS) Pharmaceutical/Chemical Engineering - Required
• 1 year or more in Pharmaceutical/Manufacturing Industry
• Excellent verbal and written communication skills.
• Advanced Proficiency in MS Word/Excel/Powerpoint.
• Multi-tasking.
• Basic Analytical Knowledge desirable.
• 21 CFR, cGMP, basic manufacturing process knowledge

Nice To Haves

• Master Degree (MS/MA) Pharmaceutical/Chemical Engineering - Preferred

Responsibilities

• 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
• 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.

Benefits

• 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 helps you enjoy your career alongside life’s many other commitments and opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level