- Posted: over a month ago
- Benefits: 401k, dental, life insurance, medical, vision,
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, 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.
• Review and recommend impact of change control requests. Recommend required level of validation
and propose plans to maintain systems in a compliant, validated state.
• Apply statistical tools and analyze results and raw data.
• Participate 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 reviews.
• Create Standard Operating Procedures (SOP’s) for new equipment/processes, as well as update
• Perform peer review of all validation documents.
• Evaluate and determine the impact of critical system work orders for validated equipment.
• Assume project validation lead to support projects of other departments.
• Create validation master plans for new systems/processes.
• Coordinate and support media fills.
• 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.
• This position has no direct reports.
• B.S. in science or engineering related field and 7 years validation experience or equivalent
combination of two-year degree and a minimum of 9 years validation experience in an aseptic
• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment,
computer systems, process control systems, equipment cleaning and sterility assurance required.
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• Experience with various types of validation test equipment, such as:
o Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.
• Prior experience (required) in the qualification of various types of sterile filling facility equipment, such
o Sterilization Technology (Steam, Dry Heat, VHP, etc)
o Temperature Mapping (Various chambers)
o Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc)
o Pharmaceutical Grade Utilities
o Process Validation
o Cleaning Validation
• Hands-on skills are necessary.
• Expertise with Windows based Personal Computers.
• 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.
Exelead, Inc.Why Work Here?
Join a team and company that truly changes lives!
At Exelead, we approach contract manufacturing with focused expertise on liposomal and PEGylated formulations to treat rare diseases and small or underserved populations. We specialize in the development and manufacture of lipid-based, parenteral drug products, and our team has more than 20 years' experience working with a wide range of preclinical, clinical and commercial customers.
6925 Guion Road Indianapolis. IN 46268Indianapolis, IN