Computer system Validation Engineer Job

· Expertise in generation & review of life cycle documents like Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) protocols. Change controls, Summary reports, Deviation reports, Requirement Traceability matrix (RTM), Requalification protocols, Standard Operating Procedures (SOPs), and Preventive maintenance forms.

· Participating in the resolution & protocol deviations or discrepancies.

· SIP, CIP validation on manufacturing equipment.

· Work with Kaye AVS for temperature mappings.

· Develop the interface with facilities & manufacturing person along with equipment SMEs.

· Support cleaning & sterilization validation of new equipment in bulk capacity expansion projects.

· Work with Controlled Temperature Units like refrigerators, autoclaves, incubators, freezers, walk in cold-rooms.

· Experience working on critical utilities like HVAC system, Water for Injection (WFI) system, and compressed gases system.

· Ability to work well with diverse, multi-disciplined groups.

· Ability to effectively communicate with management and fellow project team members.

· Ability to negotiate/compromise with other project team members to achieve project goals.

· Responsible for leading a project and oversight of validation deliverables among multiple groups in the organization.

· Ensures clear communication and alignment between cross-functional groups.

· Foster cross-departmental relationships (QC, Materials Management, Manufacturing, QA, and site leadership) by representing Validation at team meetings.

· Establish and/or modify written procedures and standards for critical processes such as quality control, change management, manufacturing, lab practices etc.

· Review existing SOPs, Work Instructions, Protocols, Training Records, System Documentations, and Vendor Documents etc. to make sure they are up to date with current regulatory guidelines.

· Authors, executes and/or reviews validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations.

· Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.

· Schedules and executes validations per standard operating procedures and regulatory guidelines.

· Lead assigned validation related investigations and continuous improvement efforts on every aspect of validation.

· Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients

· Problem solving and troubleshooting in Drug Product Validation by conducting research to aid in resolution of issues that arise.

· Perform technical reviews and interpret data for accuracy of performance for completed validations/revalidations.

· Make sure new implementation are qualified in compliance with general industry standards, guidelines, and other FDA (Food and Drug Administration) regulations.

· Use Good Engineering practice on assigned duties.

· Revising and maintaining assigned validation procedures.

· Proficient with Microsoft Office – Word, Excel, PowerPoint, Project.

· Utilize various third party or internally developed software tools such as TrackWise, to track validation activities.

· Ensure these data / document management tools are configured as per current regulatory guidelines (21 CFR Part 11) and internal compliance SOPs to only allow access to authorized users, preserve audit trails and update version controls as necessary.

Bachelor's Degree is required in Computer Science or Software Engineering or Information Technology or Data Analytics & Business Statistics.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave