Process Engineer

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Bonuses or performance-based awards

401(k) matching contribution

Diverse health and insurance benefits

Job summary

A leading pharmaceutical company is seeking a Process Engineer to oversee validation protocols and manage post-approval projects. The ideal candidate has at least 2 years of experience in the Pharmaceutical/Manufacturing Industry, holds a Bachelor's Degree in Pharmaceutical/Biomedical Engineering, and possesses strong analytical skills. The role offers a competitive salary ranging from $80,000 to $95,000, along with performance-based incentives and comprehensive health benefits.

Qualifications

• 2 years or more in the Pharmaceutical/Manufacturing Industry.
• Basic analytical knowledge desirable.
• In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.

Responsibilities

• Prepare validation protocols & reports for manufacturing processes and cleaning qualifications.
• Manage post-approval projects; coordinate with cross-functional teams.
• Analyze statistical data for conformance with established quality requirements.
• Oversee development of new processes or troubleshoot existing ones.
• Assist in investigations to identify root causes and define corrective actions.
• Initiate change controls and planned deviations when required.

Skills

Excellent verbal and written communication skills

Proficiency in MS Word/Excel/PowerPoint/Microsoft Project

Education

Bachelor’s Degree in Pharmaceutical/Biomedical Engineering

Master’s Degree in Pharmaceutical/Biomedical Engineering

Job description

Process Engineer – Amneal Pharmaceuticals

Join to apply for the Process Engineer role at Amneal Pharmaceuticals.

Job Overview

Process 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 Statement

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.