Validation Engineer II

The Validation Engineer II is responsible for providing support to all validation activities within the Indianapolis site.

This position is 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).Research, write, coordinate, and execute qualification protocols including IQ, OQ, PQ for process, equipment, facility, and utility.

Execute commissioning and qualification test functions in support of approved protocolsReview, summarize and present data in a Summary Report for management review and approvalPerform requalification, data integrity assessments and periodic performance reviews.

Use validation test equipment such as Kaye Validator, Val Probe, Vaisala Data Loggers, PLC Software such as A-B and Honeywell, and Heat BlocksAcquire and demonstrate the ability to use site documentation systems such as : Quality Tracking System, Document management systems, Training, Maintenance management etc.

Review and recommend impact of change control requestsRecommend required level of validation and propose plans to maintain systems in a compliant, validated stateApply statistical tools and analyze results and raw dataParticipate in projects for new systems and equipment (associated functions include project estimating and budgeting, scheduling and overall project coordination)Review process changes and validation in support of Annual Product reviewsCreate Standard Operating Procedures (SOP’s) for new equipment / processes, as well as update existing validation life cycle management SOPsPerform peer review of all validation documentsEvaluate and determine the impact of critical system work orders for validated equipmentAssume project validation lead to support projects of other departmentsCreate validation master plans for new systems / processesCoordinate and support media fillsPerforms special projects and other duties as assignedHandling of wastes (including hazardous wastes);

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 Employee must be available to work various shifts and weekends to support the Validation Schedule.

Who You Are : Minimum Qualifications : Bachelor’s Degree in Science (Biology, Chemistry, Biochemistry, etc.) or Engineering (Chemical Engineering, Mechanical Engineering, Electrical Engineering, etc.

with 3+ years’ validation experience in aseptic pharmaceutical settingORAssociate’s Degree in Science (Biology, Chemistry, Biochemistry, etc.

or Engineering (Chemical Engineering, Mechanical Engineering, Electrical Engineering, etc.) with 5+ years’ validation experience in aseptic pharmaceutical setting Preferred Qualifications : Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning, and sterility assuranceExperience with various types of validation test equipment, such as : o Kaye Validator, Val Probe, PLC, Temperature / Pressure standardsExperience in the qualification of various types of sterile filling facility equipment, such as : Sterilization Technology (Steam, Dry Heat, VHP, etc)Temperature Mapping (Warehouse, Freezers, Refrigerators, Cold Rooms)Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc)Pharmaceutical Grade Utilities (Steam, WFI, Compressed Air, Nitrogen Gas)Process ValidationHands-on skillsExpertise with Windows-based Personal Computers PC skills with spreadsheets, word processing and databasesHighly organized, conscientious, and self-motivatedAbility to work and make decisions independently as well as with a teamAbility to work in technically and mentally demanding situationsStrong verbal and written communications skillsAbility to climb stairs and ladders to perform the functions of this job