Senior Validation Engineer
About The Position
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.
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
- 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.
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
