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25 days old

Validation Engineer

Kelly Services
Indianapolis, IN 46202
Validation Engineer (Indianapolis, IN)

Client in Medical Devices, expanding, is currently hiring a Validation Engineer to support to all validation activities within the Indianapolis site (Oversee 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, etc.)


This position is a Direct Hire.


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 Systems, Document Management Systems, Training and other Maintenance management files.

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 (SOPs) for new equipment/processes, as well as update existing SOPs.

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 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.


Scope:

This position has no direct reports.


Background Qualifications:

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 pharmaceutical setting.

Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning and sterility assurance required.

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 as: Sterilization Technology (Steam, Dry Heat, VHP, etc.), Temperature Mapping (Various chambers), Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc.), Pharmaceutical Grade Utilities.

Process Validation / 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.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-02 Expires: 2022-06-02

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Validation Engineer

Kelly Services
Indianapolis, IN 46202

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