Validation Engineer (Manufacturing)

Description:

The Validation Engineer is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.

Essential Functions:

• Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria
• Performs re-qualification of equipment, facility and utilities as required
• Responsible for creating validation project and validation progress reports - weekly and monthly
• Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements
• Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management.
• Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement.
• Performs engineering assessment and writes investigation reports for non-conformance

Additional Responsibilities:

• Assists with engineering projects and performs other duties as assigned.

 

Education:

• Bachelors Degree (BA/BS) BS: in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required

Experience:

• 1 year of experience in engineering, pharmaceutical industry, cGMP environment

Skills:

• Proficient in MS Office. - Advanced
• Excellent technical writing skills - Intermediate
• Excellent oral and written communication skills. - Advanced
• Must be able for follow direction and execute assigned work independently, after initial training is completed - Advanced
• Ability to work both independently and in conjunction with a team - Advanced

Specialized Knowledge:

• Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents

The base salary for this position ranges from $70,000 to $110,000 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.

 

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.