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1+ months

Validation Specialist II or III

Kelly Services
Indianapolis, IN 46202
**Kelly Services is actively recruiting for a Validation Specialist II or III for a Direct Hire opportunity in Greater Indianapolis area, 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, 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 (SOPs) 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 employees 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 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:


o Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.


Prior experience (preferred) in the qualification of various types of sterile filling facility equipment, such as:


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.


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**\#TJP2022_SPEC**

**\#P1**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-06-27 Expires: 2022-09-08

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Validation Specialist II or III

Kelly Services
Indianapolis, IN 46202

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