Validation Specialist II - NW Indy
- Immediate Opportunities - Life Sciences
- Indianapolis, IN, USA
- Full Time
Validation Specialist - Exelead
EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking Validation Specialist.
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).
• Research, write, coordinate, and execute validation protocols including IQ, OQ, 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 revalidations.
• 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 System, 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.
• Performs 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.
• B.S. in science or engineering related field and 5 years validation experience or equivalent
• combination of two-year degree and a minimum of 7 years validation experience in an aseptic
• pharmaceutical setting.
• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment,preferred.
• Experience with various types of validation test equipment, such as: Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.
• Prior experience (preferred) in the qualification of various types of sterile filling facility equipment, such as:
• Sterilization Technology (Steam, Dry Heat, VHP, etc)
• Temperature Mapping (Various chambers)
• Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc)
• Pharmaceutical Grade Utilities
• Process / Cleaning Validation
Full package of benefits