Validation Engineer - 2nd Shift

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Validation Engineer for the 2nd shift to enhance pharmaceutical systems. In this pivotal role, you will be responsible for executing validation activities, conducting development studies, and providing technical input for site transfer projects. Your expertise will ensure compliance with quality and safety standards while collaborating closely with maintenance teams. This position offers a dynamic work environment where your contributions will significantly impact the success of engineering projects. If you have a passion for improving processes and systems in the pharmaceutical industry, this opportunity is for you.

Qualifications

• 2+ years of experience in engineering or pharmaceutical industry.
• Bachelor's degree in a relevant field is required.

Responsibilities

• Design and execute validation document activities including FAT, IQ, OQ, and PQ.
• Collaborate with teams for equipment installation and validation.

Skills

MS Office

Technical Writing

Communication Skills

Independent Work

Team Collaboration

Education

Bachelor's Degree in Pharmaceutical Manufacturing, Engineering, Science

Job description

Join to apply for the Validation Engineer - 2nd Shift role at Amneal Pharmaceuticals.

Description: The Validation Engineer II is responsible for performing validation and engineering activities, conducting development studies, analyzing, and assisting in improving pharmaceutical systems and processes.

Essential Functions:

1. Design, review, and execute validation document activities such as Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment/utilities/facilities, and generate reports summarizing results, specifications, and acceptance criteria.
2. Perform re-qualification of equipment, facilities, and utilities as required.
3. Create validation project and progress reports on a weekly and monthly basis.
4. Participate in evaluating failures and out-of-specification results impacting compliance with quality, safety, and other design requirements.
5. Provide technical input and develop strategies for domestic and international site transfer projects, with regular status updates to management.
6. Collaborate closely with maintenance and facility teams to complete new equipment installation, commissioning, and validation as per project requirements.
7. Perform engineering assessments and write investigation reports for non-conformance issues.

Additional Responsibilities:

• Assist with engineering projects and perform other duties as assigned.

Qualifications:

Education:

• Bachelor's Degree (BA/BS) in Pharmaceutical Manufacturing, Engineering, Science, or a relevant field (Required).

Experience:

• At least 2 years of experience in engineering, pharmaceutical industry, or cGMP environment.

Skills:

• Proficient in MS Office (Advanced).
• Excellent technical writing skills (Intermediate).
• Excellent oral and written communication skills (Advanced).
• Ability to follow directions and execute work independently after training (Advanced).
• Ability to work independently and in teams (Advanced).

Specialized Knowledge:

• Ability to read, understand, and verify piping & instrument diagrams, engineering layouts, drawings, and documents.

About Us: Amneal is an Equal Opportunity Employer committed to diversity and inclusion.