Validation Consultant Job Listing at Kelly Services in Tampa, FL (Job ID US3546105_BH9765259)

Description

Sterilization Validation Consultant | Tampa, FL

On-Site | 1 + Year Contract

 

Job Listing Detail:

**Must have Sterilization Process Experience**

This role supports the Maintenance of Business (MoB) Process Engineer and Validation Department as a sterilization validation consultant. The Sterilization Validation Consultant has responsibility to provide quality and technical support for all validation processes & documentation as part of the sterilization qualification activities to ensure continuity of supply of products. Provide hands on support and guidance for site qualification activities related to sterilization processes. Experienced consulting in the sterilization and manufacturing of drug product formula ingredients and packaging components. Knowledge and experience working with radiation, EO and steam sterilization, developed and validated sterilization cycles and procedures, management of microbiological laboratories, built and validated various sterilization systems, quality and microbiological audits within various manufacturing environments.

 

Responsibilities:

 

• Provide consultative knowledge and insight by performing operational assessments in sterile processing.
• Support testing readiness for testing cycles associated to the sterilization validation activities.
• Coordinate, plan, review and execute of validations. Track and report out on test readiness and execution status.
• Experience in development and execution of IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort. To prepare and update of Validation strategy, Process validations, Risk Assessment and any validation documents/reports required for sterilization qualification project.
• Knowledge on EtO, Xray, Gamma, and E-beam sterilization cycles. To review and provide guidance on sterilization cycles and provide support on the implementation of sterilization technology process.
• Experience in execution of Dry Heat and Temperature Mapping. Expert with Dry Heat Sterilization standards and current guidelines.
• Prepare, review and/or update applicable SOP or other documentation associated with sterilization changes.
• Participate in contract negotiations and proposals, quoting process. Coordinate tests required with Laboratories for Micro assessment and VDmax as part of the validation. Support issuing associated documentation to transfer, receipt, delivery of sample materials.
• Knowledge on Chemistry and Microbiology laboratory tests like Bioburden, Assay and Impurities and USP 61.
• Experience with visually examining items for damage, deterioration, or imperfections such as rust, pitting, and cracks. Be able to recommend/confirm pouching material needed to withstand the sterilization cycle.
• Knowledge on sterilized items comparing control tests to determine that correct parameters (e.g. time, temperature, and pressure).

 

Qualifications:

 

• Bachelor's Degree in Sciences.
• Minimum 5 years of Sterile Processing and process improvement experience or consulting position.
• Experience and knowledge in sterilization technologies such as EO, Dry Heat, Xray, Gamma, E-beam strongly preferred.
• Experience leading and working with other teams including third party and managed services support.
• Self-driven, self-motivated with ability to motivate & influence a core team to meet the project objectives.
• Excellent team coordination and communication (oral and written) in a cGMP environment.
• Excellent project management, conflict management and coordination skills

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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