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1+ months

Sr. Validation Engineer

Kelly Services
San Diego, CA 92108
**Kelly is actively recruiting for Direct Hire Sr. Validation Engineer in San Diego, CA.**


**Summary:**


Conducts validation studies in accordance with current industry standards and guidelines for the qualification of equipment, utilities and facilities and the validation of supporting manufacturing systems and processes. Applies acquired experience to further develop current validation practices and mentor validation engineers.


**Primary responsibilities for role:**


+ Research and developed qualification and validation protocols, execution of the studies, analysis of the resulting data and development of the final report.

+ Evaluates and analyzes data. Develops and presents recommendations based on the data analysis.

+ Completes studies within validation project timelines and communicates project updates within the validation department.

+ Investigates and documents all validation related failures including determination of assignable cause. Determines impact of failures on validation study.

+ Complete final written reports which analyze and summarize results.

+ Participates in departmental meetings and cross functional team meetings as required. Facilitates team meetings as required.

+ Applies acquired validation experience to develop, enrich and streamline current validation practices.

+ Mentors, trains and supervises less experienced validation engineers.

+ Evaluates and communicates the status of current validation projects to validation management.


**Knowledge, Skills, and Abilities:**


+ Excellent technical writing and analytical skills.

+ Experience in a Biologics, Medical Device or FDA related manufacturing facility.

+ Familiarity with a cGMPs and industry and federal guidelines required.

+ Proficient in computer applications such as Word, Excel, and Access. Strong interpersonal skills required for interaction with Manufacturing, QA, QC and RA personnel

+ Knowledge of information systems such as LIMS systems and laboratory systems such as HPLCs and GCs Excellent technical writing and analytical skills. Experience with writing regulatory submission reports and related qualification and validation reports.


**Education:**


+ BS degree in Computer Science, Engineering, Biology, Chemistry, Physical Science or equivalent. Experience in related Quality Assurance, Quality Control or Engineering function is acceptable. Technical writing skills required for regulatory submission related qualification and validation reports.


**Experience:**


+ Minimum seven years direct validation experience preferred


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


\#TJP2021_SPEC


**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: 2021-08-27 Expires: 2021-10-28

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Sr. Validation Engineer

Kelly Services
San Diego, CA 92108

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