Job Posting: Validation Specialist

      Indianapolis, IN


      Position Overview


      This position is responsible for providing support to all validation activities within the Indianapolis site. Responsible for compliance with all applicable cGMP, FDA, and EU regulations as they pertain to validation (21 CFR 210 &211; 21 CFR Part 11;EU GMPs; ICH Q7, Q8, Q9, Q10).



      Major Position Activities & Responsibilities


      • Research, write, coordinate, and execute validation protocols including IQ, OQ, and PQ for process, equipment, facility, utility, computer, and cleaning validation. Execute validation test functions in support of approved protocols. Review, summarize and present data in a Summary Report for management review and approval. Perform re-validations.
      • Use validation test equipment such as Kaye Validator, Val Probe, PLC Software such as A-B and Honeywell, and Heat Blocks.
      • Acquire and demonstrate the ability to use site documentation systems such as quality tracking systems, document management systems, training, maintenance management, etc.
      • Apply statistical tools and analyze results and raw data.
      • Participate in projects for new systems and equipment.
      • Create Standard Operating Procedures (SOP’s) for new equipment/processes, as well as update existing SOPs.
      • Perform peer review of all validation documents.
      • Perform special projects and other duties as assigned.
      • As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.



      Background Qualifications


      • B.S. in science or engineering related field
      • Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment preferred
      • Expertise with Windows based Personal Computers
      • Hands-on skills are necessary
      • Above average PC skills with spreadsheets, word processing and databases.
      • Employee must be self-motivated, highly organized, and conscientious. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required.
      • Employee must have sufficient mobility to work in a process environment.  The employee will be required to climb stairs and ladders to perform the functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
      • Employee must be available to work various shifts and weekends to support the Validation Schedule


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