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Job OverviewProcess Engineer reports to the Manager of Technical Services and plans, executes, and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post‑approval projects.
Responsibilities- 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.
- Analyze statistical data, products or functional specifications to determine conformance with standards and established quality requirements.
- Coordinate/oversee the development of new processes or troubleshoot existing ones.
- 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.
Qualifications
Education:
- Bachelor’s Degree (BA/BS) in Pharmaceutical/Biomedical Engineering – Required.
- Master’s Degree (MS/MA) in Pharmaceutical/Biomedical Engineering – Preferred.
Experience:
- 2 years or more in the Pharmaceutical/Manufacturing Industry.
Skills:
- Excellent verbal and written communication skills – Advanced.
- Proficiency in MS Word/Excel/PowerPoint/Microsoft 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.
Compensation & Benefits
The salary for this position ranges from $80,000 to $95,000. 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, for this position within the first 12 months. 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. Amneal’s total rewards program includes above‑market, diverse and robust health and insurance benefits, a significant 401(k) matching contribution, and employee well‑being programs.
EEO StatementAmneal 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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