Validation Engineer - Medical Device Manufacturing

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Validation Engineer – Medical Device Manufacturing at a prestigious Fortune 500® company working in West Hills, CA.

This is a 6-month temporary position at 40 hours per week.  Pay: $32.93/hr. 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (keig126@kellyservices.com) however your resume must be received via the “submit now” button included within.

Position Summary:

This position will mainly be focused on writing and executing equipment validations associated with the manufacture of In Vitro Diagnostic (IVD) Medical Devices during the preparation and transfer of operations from one facility to another. This move is scheduled to start in Q4 2019.The candidate will also work closely with cross functional teams (R&D, Manufacturing, Quality Control) to help prepare their equipment, materials and laboratories for the move. The main function of this position is to support the physical move of the business, so it will require flexibility and motivation to help with “other duties as assigned”.

Position requires working knowledge and proven experience with Installation Qualification (IQ), Operational Qualification (OQ), performance qualification (PQ), cleaning validation in support of the processes and equipment validations. This will all be done under the guidance of the Technical Operations Group.

Key Responsibilities:

• Write new validation (IQ/OQ/PQ) protocols for existing equipment
• Transfer existing validation (IQ/OQ/PQ) protocols to new standard templates
• Execute IQ/OQ/PQ protocols
• Write IQ/OQ/PQ reports
• Write new EQ (Equipment Specification) documents for existing equipment
• Update existing EQ documents, where needed
• Work with Technical Operations team to help R&D, Operations, and Quality Control prepare equipment & materials prior to the move.
• Willingness to be flexible and participate in other activities, as assigned, to help the business prepare for the move. This may include, but not limited to:

• Updating non-validation type documents
• Set-up of materials, equipment at destination site
• Organization/coordination of equipment movement
• Assistance with cleaning validations
• Other duties as assigned
• Willingness to participate or lead PPI Business System Kaizen and 5S events
• Preferred – Lean or Six Sigma exposure
• Mindset for continuous improvement
• Adhere to relevant Medical Device / pharmaceutical regulations and current interpretations affecting product, process, equipment, and cleaning validation.
• This position requires a high level of organization
• Promote a collaborative Team environment that fosters creativity, innovation and high performance.

Minimum Requirements:

• Bachelor’s degree (or higher) required, with majors in Engineering or Natural/Life Sciences.
• At least 3 years’ relevant experience in IVD/medical device arena required
• Working knowledge & proven experience with equipment qualification (IQ/OQ/PQ), cleaning validation, and computer/automation systems.
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.
• Excellent use of Microsoft Office Suite.
• Must work well with a cross functional team, and be ready to serve our internal “Customers” (Operations, Research, Quality Control departments) on a daily basis
• Performs all job duties in a safe manner, consistent with the Code of Ethics and the
 

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.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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