Validation Engineer III
Company: Amneal Pharmaceuticals, Inc.
Posted on: June 12, 2021
- 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.
- Design, develop and execute validation documents, define
- 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
- Oversee the collection of equipment manuals from vendors and
other required documents as well as Factory Acceptance Test (FAT)
- 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
- 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
- Assist with Engineering projects as needed. Supervise and train
staff as needed. Perform other duties as assigned.
- Bachelors Degree (BA/BS) Degree in Pharmaceutical
manufacturing, Engineering, Science or relevant field -
- 5 years or more in 5 or more years relevant experience in
Engineering, pharmaceutical industry, cGMP environment with
- Proficient in MS Office. - Advanced
- Excellent technical writing skills. - Advanced
- Excellent oral and written communication skills. -
- 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
- Knowledge of Good Documentation Practices, Engineering
Qualification Procedures a must. Reads, understands and verifies
piping & instrument diagram, engineering layout, drawing and
Keywords: Amneal Pharmaceuticals, Inc., Westport , Validation Engineer III, Other , Brookhaven, Connecticut
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