Job Summary
Responsibilities
The Validation Engineer is specialized in computerized systems validation and knowledgeable in MES (EBR) , historian(QMIB), LAB -X and other manufacturing applications. Provides technical & documentation support for manufacturing process and associated computer systems. Also compliance knowledge on various aseptic manufacturing processes (sterilization, isolator technology, clean rooms, computerized systems, etc). Uses his/her expertise to maintain industry standards within the company.
The focus of the Validation Engineer is on technical and documentation aspects of the department and typically does not have direct report. The Validation Engineer must have excellent verbal and written communication skills as this position interacts directly with multiple departments at the site, regional and global levels.
Job Responsibilities:
- Schedules and executes computer system qualifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates for approval.
- Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
- Participates in dry running the manufacturing system applications and develops the test scenarios, test environments, test scripts.
- Develops and updates full life cycle documents includes, URS, FDS, DS, risk assessments, impact assessment, FMEAs and test and qualification protocols.
- Develops/improves validation programs as needed to remain current with cGMPs and industry standards
- Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
- Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
- Authors validation master plans and validation project plans outlining qualification requirements
- Authors the documentation needed for MES(EBR), Historian(QMIB), manufacturing applications and infrastructure like industrial data center, etc.
- Provides technical support for Investigations, Action Plans, Change Controls and Risk Assessments as required. Generates innovative solutions to solve difficult problems that may impact multiple disciplines
- Additional projects and tasks as assigned.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Job Requirements: