Kelly Services Validation Engineer in Irvine, California

Validation Engineer - Irvine, CA - Contract

In this role, you will support validation of new and existing equipment and processes for production line usage. In addition, you will be responsible for creating and executing validation procedures to support company goals.

Validation Activities:

  • Development and revision of validation protocols and procedures, develop test plan traceability matrix, qualification and re-qualification of process equipment (IQ/OQ/PQ) , and prepare reports.

  • Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP, handling any deviations associated with these activities.

  • Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Requalification)

  • Perform process qualification for new equipment and new technologies.

  • Author validation protocols and engineering studies.

  • Contribute to provide experimental data obtained during the validation activities.

  • Perform or oversee risk assessments for Validation.

  • Participate in the improvement and remediation of products.

  • Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.

  • Meet established validation and revalidation milestones according to approved validation plans that do not adversely impact production schedule nor audit readiness.

  • Technical reports executed on time and with the right expectations.

  • Technical/scientific responsibility as member of the site Subject Matter Experts (SME) team.

Required:

  • 2+ years of experience with manufacturing engineering or validation experience.

  • Understanding of manufacturing processes and related process equipment.

  • Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.

  • Proficient in writing and reviewing protocols and technical reports.

  • Experience working in the medical device industry preferred.

  • Experience working with a sterile packaging environment a plus.

Education:

  • Bachelor's degree in Engineering or equivalent years of relevant engineering-level experience

Work Authorization:

  • Must be able to work in the United States without sponsorship. Workers must have US Work Authorization prior to start.

Kelly does not expense relocation costs or work authorization/sponsorship costs.

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. For immediate consideration, apply directly to this position and send me a WORD DOCX resume at Deas172@kellyservices.com to advise of your submittal.

About us

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

  • Competitive pay

  • Paid holidays

  • Year-end bonus program

  • Recognition and incentive programs

  • Access to continuing education via the Kelly Learning Center

Why Kelly ® ?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in

industry leading organizations. Top companies throughout the world have trusted Kelly as a premier

source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm

with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety

and flexibility of working on short term project engagements, or prefer contract-to-hire or direct

hire placement with our clients, apply with Kelly to explore opportunities that suit your specific

professional interests.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.