Senior Validation Engineer

Amneal

5d • $100,000 - $120,000

About The Position

Description: The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management. Essential Functions: Design, develop and execute validation documents, define validation strategy. 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 Prepare and review various documents using QUMAS software.Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, initiation and review of change controls. Develops User Requirements Specification (URS) and Design Specifications. Oversee the collection of equipment manuals from vendors and other required documents as well as Factory Acceptance Test (FAT) execution. Design and develop test strategy and methodology for the validation of complex equipment. Manage GMP documentation by supporting cGMP programs including: Risk Analysis, Change Control, and Standard Operating Procedure and Notice of Investigation (NOI)/Corrective Action and Preventative Action (CAPA). Partner with management, technical peers, and negotiate with vendors to gain consensus on design, testing and methodology. Develops/updates operational and engineering related standard operating procedures to comply with cGMP and regulatory requirements. Additional Responsibilities: Assist with Engineering projects as needed. Supervise and train staff as needed. Perform other duties as assigned. Qualifications Education: Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required Experience: 5 years or more in 5 or more years relevant experience in Engineering, pharmaceutical industry, cGMP environment with bachelors Skills: Proficient in MS Office. - Advanced Excellent technical writing skills. - Advanced 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: Knowledge of Good Documentation Practices, Engineering Qualification Procedures a must. Reads, understands and verifies piping & instrument diagram, engineering layout, drawing and documents. The salary for this position ranges from $100,000 to $120,000. 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, 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.

Requirements

• Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
• 5 years or more in 5 or more years relevant experience in Engineering, pharmaceutical industry, cGMP environment with bachelors
• Proficient in MS Office.
• Excellent technical writing skills.
• Excellent oral and written communication skills.
• Must be able for follow direction and execute assigned work independently, after initial training is completed.
• Ability to work both independently and in conjunction with a team
• Knowledge of Good Documentation Practices, Engineering Qualification Procedures a must.
• Reads, understands and verifies piping & instrument diagram, engineering layout, drawing and documents.

Responsibilities

• Design, develop and execute validation documents, define validation strategy.
• 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
• Prepare and review various documents using QUMAS software.
• Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, initiation and review of change controls.
• Develops User Requirements Specification (URS) and Design Specifications.
• Oversee the collection of equipment manuals from vendors and other required documents as well as Factory Acceptance Test (FAT) execution.
• Design and develop test strategy and methodology for the validation of complex equipment.
• Manage GMP documentation by supporting cGMP programs including: Risk Analysis, Change Control, and Standard Operating Procedure and Notice of Investigation (NOI)/Corrective Action and Preventative Action (CAPA).
• Partner with management, technical peers, and negotiate with vendors to gain consensus on design, testing and methodology.
• Develops/updates operational and engineering related standard operating procedures to comply with cGMP and regulatory requirements.
• Assist with Engineering projects as needed.
• Supervise and train staff as needed.
• Perform other duties as assigned.

Benefits

• 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, with this position within the first 12 months.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees