Associate Process Engineer

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Short-term incentive opportunities

401(k) matching contribution

Comprehensive health benefits

Job summary

A leading pharmaceutical company in New Jersey is seeking an Associate Process Engineer to execute Process and Cleaning Validation assignments. The successful candidate will prepare validation reports, analyze data for standard compliance, and assist in process troubleshooting. A Bachelor's degree in Pharmaceutical or Chemical Engineering is required, along with a minimum of one year in the pharmaceutical industry. The position offers a salary between $65,000 and $80,000 and includes competitive benefits.

Qualifications

• One year or more in Pharmaceutical/Manufacturing Industry.
• Basic Analytical Knowledge desirable.
• Knowledge of 21 CFR, cGMP, and basic manufacturing processes.

Responsibilities

• Prepare validation protocols and reports for manufacturing process qualifications.
• Analyze statistical data and product specifications for conformance.
• Coordinate development of new processes or troubleshoot existing ones.

Skills

Excellent verbal and written communication skills

Proficiency in MS Word/Excel/PowerPoint

Multi-tasking

Education

Bachelor's Degree in Pharmaceutical/Chemical Engineering

Master's Degree in Pharmaceutical/Chemical Engineering

Job description

Job Title: Associate Process Engineer

Company: Amneal Pharmaceuticals

Job Description

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

Additional Responsibilities

• 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

Education

• Bachelor's Degree (BA/BS) in Pharmaceutical/Chemical Engineering – Required
• Master's Degree (MS/MA) in Pharmaceutical/Chemical Engineering – Preferred

Experience

• One year or more 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

Salary and Benefits

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.