Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Support and witness Site Acceptance Testing (SAT) in coordination with equipment vendors.

· Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing, facility, and utility systems.

· Perform commissioning and qualification activities for systems including cleanrooms, filling line equipment, packaging lines, autoclaves, lyophilizers, water systems, gas systems, and associated utilities.

· Document test execution results and ensure compliance with project requirements and applicable regulatory standards.

· Coordinate with vendors, engineers, and cross-functional stakeholders during testing and qualification activities.

· Support deviation investigations, issue resolution, and CAPA implementation related to commissioning and qualification processes.

· Responsible for all respects of validation processes like- documenting commissioning activities, establishing the process, and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes in the Plant site.

· General SOPs and Work Instructions.

· Validation Policies and Procedures

· Elicit and generate Requirements for software/systems.

· Perform Risk Assessments or Impact Assessments

· Generate and execute Test Scripts/Protocols to ensure the system meets its intended use.

· Deviation management based on out of specification results.

· Responsible for developing protocols performing executions and drafting summary reports for validation activities like:

· Design qualification (DQ)

· Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), FAT/SAT generation, Engineering Turnover Packages, P&ID walkdowns

· Supplemental qualification, requalification methods for equipment Process, Cleaning, facilities Computer software used and for Method developed.

· Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations/discrepancies. Oversees and reviews validation area processes.

· Responsible for assisting QA, Production and Engineering personnel during inspections and audits with System Owners, Lab Managers, QA, SME and Vendors with various qualification activities. and leading the Vendor qualification activities by defining the strategy and implementation from beginning to end stages of the project.

· Responsible for performing qualification studies on HVAC, Clean Air, Nitrogen tank, temperature control units and other equipment’s used in manufacturing facility.

· Responsible for activities for cleaning verification and process validation and gap analysis as per FDA and ICH requirements.

· Performing various types of testing such as Bubble point test, Flow star test for filters and Pressure Decay test for Gloves, microsphere sieve Processing and material of construction verification.

Bachelor's Degree is required in Pharmacy or Pharmaceutical Science or Pharmaceutics.

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