Associate Process Engineer
Listed on 2026-10-06
-
Engineering
Quality Engineering, Process Engineer, Validation Engineer
Job Title:
Associate Process Engineer
Company:
Amneal Pharmaceuticals
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 prepares reports under supervision.
Essential Functions- Prepare validation protocols and reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study
- Analyze 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
- Perform other functions as required or assigned
- Comply with all company policies and standards
- Initiate Change Controls and Planned Deviations when required
- Review manufacturing/Packaging batch records and Engineering qualification documents
- Bachelor's Degree (BA/BS) in Pharmaceutical/Chemical Engineering – Required
- Master's Degree (MS/MA) in Pharmaceutical/Chemical Engineering – Preferred
- One year or more in Pharmaceutical/Manufacturing Industry
- Excellent verbal and written communication skills – Advanced
- Proficiency in MS Word/Excel/PowerPoint – Advanced
- Multi‑tasking
- Basic Analytical Knowledge desirable
- 21 CFR, cGMP, basic manufacturing process knowledge
Salary ranges from $65,000 to $80,000. 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, within the first 12 months. Compensation is determined based on qualifications, experience, geographic location and other relevant skills. A comprehensive benefits program includes competitive health and insurance benefits, a significant 401(k) matching contribution and programs promoting employee well‑being.
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.
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