Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Responsible for cleaning validation Study on equipment used manufacturing production. Understanding The analytical testing like Total organic carbon measurement, determining Conductivity of samples, understanding of caustic wash, acid wash, Quality monitoring for Microbial growth by testing of bioburden and endo toxins.

· Responsible for Performing Clean-in-place, Clean-out of-place, sterilization place study to qualify the cleaning efficiency of the equipment's preventing product carry over.

· Responsible for all respects of validation processes like- documenting commissioning activities, establishing the process, and developing and performing qualification studies for Design, installation operational and Performance of equipment, requalification studies, GAP analysis to provide a high degree of assurance that equipment/processes/Method will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.

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

· Responsible for Performing qualification includes material of construction using chemicals, monitoring temperature using related instrument, swab sampling sample collection for micro testing analyzing the reports.

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

· Generate various technical documents such as protocols for method validation, Standard operating procedures (SOP’s), Specifications and reports.

· Generate 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.

· Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, 503B, ICH guideline knowledge.

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

· Perform various analytical testing using analytical instruments such as Assays, Content uniformity.

· Responsible for performing stability studies, Cleaning method studies, Raw material and packaging material testing.

· Perform Calibrations and qualification studies for Analytical instruments such as UV, FTIR, HPLC.

· Ability for interpretation of data generated by various developmental analytical tests including Dissolution, Blend Uniformity, Assay, HPLC, Particle size, Spectroscopy, etc.

· Write, execute, and review complex protocols and coordinate validation activities from other departments

· Train other validation personnel

Bachelor's Degree is required in Chemistry or Pharmacy or Pharmaceutical Engineering.

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