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22 days old

Sr. Validation Engineer

Kelly Services
Arcadia, CA 91007
Kelly Science & Clinical is excited to be hiring a **_Senior Validation Engineer_** for a leading Cell and Gene Therapy Manufacturing company in Arcadia, CA! The **_Sr. Validation Engineer_** will lead and support validation projects to bring up a cGMP facility. You will be responsible to oversee and support validation projects of medium to high complexity (equipment, utilities, facilities, processes, computerized systems, etc.) in areas such as determining validation approach, engineering studies, documentation generation and review (specifications, protocols, risk-assessments, etc.), and execute alongside in-house and validation contractors. With support, you will manage contractors and act as validation signatory representative to review and approve validation lifecycle documentation for GMP use. The ideal candidate has a strong understanding of the validation lifecycle and quality systems, creative in their problem solving, and flexible to accommodate shifting priorities in a fast-paced startup environment.


**Job Duties Include:**


+ Lead and support GMP validation projects of medium to high complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources

+ Oversee, supervise, and train junior engineers in cGMP validation best practices

+ As required, develop qualification and validation protocols, execute the associated studies, analyze the resulting data, and develop the final report

+ Serve as Validation SME for validation project scopes, approaches, and rationales

+ Develop Standard Operating Procedures to develop and mature the Validation program

+ Support validation deviation investigations and determine assignable cause alongside Validation Lead and contractors

+ Review validation lifecycle documentation, including requirements, specifications, protocols, and reports

+ Act as validation signatory representative to approve validation documentation, accountable to management and regulatory agencies

+ Support the Validation Team in any required activities to support the development, execution, or improvement of the Validation program

+ Understand the application of Data Integrity per 21 CFR Part 11

+ Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulation


**Requirements:**


+ A Bachelors degree in a science-related field, preferably Life Sciences or Engineering. Advanced degree is a plus.

+ A minimum of 5+ years of relevant Validation experience (Pharmaceutical, Life Sciences industry cGMP environment)

+ Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)

+ Strong understanding of the validation lifecycle in GMP settings

+ Knowledge of cGMP, GAMP, 21CFR part 11, GDP

+ Creative in problem-solving abilities, able to think outside the box to find solutions

+ Self-motivated and self-starter, able to work independently with minimal supervision

+ Must be proactive, results oriented, and have strong attention to detail

+ Strong written and verbal communication skills (including technical writing skills)


Apply today to start a conversation on Whats Next for your Career!


Please feel free to schedule an interview directly with Athena to learn more: https://calendly.com/athp320/interview


**Additional questions may also be e-mailed to athena.parker@kellyscientific.com**


**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** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-12 Expires: 2022-10-13

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Sr. Validation Engineer

Kelly Services
Arcadia, CA 91007

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