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).
1. Bachelor's Degree- STEM field or related
2. 7+ years of validation engineering experience with at least 3 years of Pharmaceutical experience
3. Experience with developing test plans for IQ/OQ/PQ for Autoclaves (or similar product)
4. Experience with systems related to temperature mapping equipment
5. Good communication skills-- will be interacting with customers and presenting to them
Job duties are as follows:
* 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.
* Apply statistical tools and analyze results and raw data.
* Participate in projects for new systems and equipment.
* 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.
* Performs special projects and other duties as assigned.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
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