Associate Process Engineer (Manufacturing)
Description:
The Associate Process Engineer assists with equipment qualification and related engineering documentation, including preparation of protocols, reports, and statistical data analysis to ensure compliance with quality standards. The role also supports troubleshooting, audits, and investigations by identifying root causes and recommending corrective or preventative actions.
Essential Functions:
- Support validation protocols & reports for manufacturing equipment qualification; data analysis and prepare reports;
- Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements
- Troubleshoot equipment and process issues, collaborating with cross-functional teams to implement effective solutions.
- Support engineering requirements by procuring new equipment, coordinating installation, and assisting with modifications to existing equipment and processes.
- Prepare and review manufacturing batch record and other engineering qualification documents as required
- Provide technical support to R&D and production teams, ensuring equipment and process readiness for routine and new manufacturing needs.
- Coordinate/oversee the development of new processes or troubleshoot existing ones
- Assist in preparing and executing validation protocols for both automated and manual processes, ensuring compliance with cGMP and company standards.
- 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) Electrical or Mechanical Engineering- Required
- Master Degree (MS/MA) Electrical or Mechanical Engineering - Preferred
Experience:
- 0-2 years of experience 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 base salary for this position ranges from $65,000 to $85,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, 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.
