Associate Process Engineer - Night Shift

RXinsider LTD.; Piscataway Township (NJ); Hybrid; USD 65,000 - 80,000; Full time

Benefits offered by this job

Health benefits

401(k) matching

Job summary

Amneal is seeking an Associate Process Engineer to support plant operations, validate improvements, and assist in SOPs and equipment validation. The role involves process simulations, data-driven optimization, and collaboration with cross-functional teams to drive quality and efficiency.

Responsibilities include monitoring process performance, performing RCA/CAPA, and ensuring adherence to FDA regulations. The position requires a Bachelor's in engineering or related field, with a Master’s

Qualifications

• Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy or related field (Required).
• Master's degree in Engineering, Pharmaceutics, Industrial Pharmacy preferred.
• 1+ year in Engineering, Pharmaceutics, Industrial Pharmacy

Responsibilities

• Support process/validation efforts for plant operations and new manufacturing processes.
• Perform process simulations and optimization studies; implement modifications and installations at manufacturing level.
• Assist in SOPs and equipment installation, op qualifications, validation protocols and change controls.
• Analyze manufacturing data using statistical methods to drive improvements.
• Investigate deviations; perform RCA and support CAPA implementation.
• Ensure compliance with FDA regulations and cGMP; support cross-functional teams on regulatory readiness.

Skills

Process engineering

SOP writing

Data analysis

RCA

CAPA

FDA cGMP

Education

Bachelor's degree in Engineering or related field

Master's degree preferred

Job description

Job Description

Description:

The Associate Process Engineer provides support to the operation Manager/Associate Director Operation/ Engineering in implementing improvements, validation and automation to the plant operations and assist in several functions such as writing standard operating procedures (SOPs), develop process flow, review design documents related to procurement of new equipment. Help with equipment validation.

Night Shift – 12-hour per day, rotating schedule (6:00pm-6:30am) 3 days on week 1 and 4 days on week 2 of pay cycle

Essential Functions

• Support process/validation engineer; for plant operations to suggest and implement improvements; for new manufacturing processes through process and equipment validation.
• This entails completing process simulations and optimization studies and implementing modifications and process installations at the manufacturing level
• Support day-to-day manufacturing operations by monitoring process performance and identifying improvement opportunities.
• Assist in process optimization to improve yield, efficiency, quality, and equipment reliability.
• Analyze manufacturing data using statistical and analytical tools to drive data-based decision making
• Help prepare and update Standard Operating Procedures (SOPs) and help execute equipment installation and operational qualifications, validation protocols, reports, and change controls.
• Supports technical services by troubleshooting activities in the operation department. Protocol review and Development process
• Help generate reports, charts, and tables based on established statistical methods to drive process enhancements.
• Investigate process deviations and non-conformances; perform root cause analysis (RCA) and support CAPA implementation.
• Assist process/validation engineer evaluate, improve and validate current manufacturing practices or processes and equipment’s with an effort for continuous improvement towards productivity, quality, reliability and consistency.
• Provide support on various manufacturing/engineering equipment uptime.
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality standards.
• Collaborate with cross-functional teams to support continuous improvement initiatives and regulatory readiness. Communicate with vendors on possibility of material improvement.

Additional Responsibilities

• Other duties that management may from time to time assign
• Write deviation and CAPA (Corrective action and preventive action
• Assist review of process related documents

Qualifications

Education

• Bachelors Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy or related field - Required
• Master's degree in Engineering, Pharmaceutics, Industrial Pharmacy or related field - Preferred

Experience

• 1 Year or more in Engineering, Pharmaceutics, Industrial Pharmacy

The base 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, 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

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.