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18 days old

Validation Engineer

Kelly Services
Carlsbad, CA 92008
Title: Validation Engineer


Location - Carlsbad, CA


Contract 12 Months


The role is responsible for Computer Systems Validation within the Engineering group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.


The CSV Validation Engineer will be responsible for oversight of all GMP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.


This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.


What will you do?

Perform GMP computerized system validation projects in compliance with GMP, 21 CFR Part 11, Annex 11 and Data Integrity.

Ensure that GMP systems meet intended uses and comply with applicable regulations, current industry practices, policies and procedures. Validation projects may include manufacturing systems, lab systems, and steady state activities around these applications.

Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.

Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.

Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.

Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.

Coordinate and provide training and/or opportunities for career development of others.

Perform other duties as assigned.

Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.


Education

Bachelors degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.


**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** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-06 Expires: 2022-06-06

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Validation Engineer

Kelly Services
Carlsbad, CA 92008

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