Validation Engineer Job

· 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. (o 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 leading Data Integrity Remediation Project to address System Access controls, Audit Trails, 21 CFR Part 11 and Backup gaps and Secure Life Cycle program, collection, storage, maintenance, backup, recovery, archival, retirement)

· Responsible for all the aspects of Systems validation lifecycle in accordance with the FDA regulations, particularly 21 CFR Part 11, GLP and GMP.

· Responsible for assisting the project manager in documenting SOPs in the production phase.

· 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 commissioning, facilities department, and relative to production. and developing documentation, performed CIP, COP, SIP executions with COP washers and CIP UF/DF Skids.

· Responsible for performing Temperature mapping for Autoclave using temperature-monitoring device Kaye Validator 2000, Thermocouples and Biological indicators (BI’s).

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

· Require understanding of Biologics Drug Substance and/or Sterile/Parenteral drug product manufacturing (liquid and lyophilized).

· Generate various technical documents such as protocols Standard operating procedures (SOP’s), Specifications, Reports, Traceability matrix, validation master plans, change control, CAPA, and perform investigation for process deviations.

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

· Perform calibrations for pharmaceutical equipment’s such as analytical instrument and manufacturing instruments.

· Ability to interpret data from various sources such as USP NF, Protocols etc.

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

· Worked on aseptic sampling, aseptic clean hold time studies, Bioburden sample collection, TOC and Endotoxin sample collection, Rinse and negative control sample collection and SWAB sampling and evaluating the results for the acceptance, needs verification of huge data processing.

· Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA), STAT testing and drafting Remediation Plans for the project management approval after the GAP Analysis.

· Ensured that all the documentation is compliance with FDA and cGMP regulations and provided technical support to the validation group as needed.

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

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