Validation Specialist II or III

Company: Kelly Services
Location: Indianapolis
Posted on: September 24, 2022

Job Description:

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 (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.

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 Utilitieso Process Validationo 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

Keywords: Kelly Services, Indianapolis , Validation Specialist II or III, Other , Indianapolis, Indiana