Kelly Services Process Engineer in Vacaville, California
Kelly's Outsourcing and Consulting Group (KellyOCG) is currently looking to hire Process Engineers to work for one of our top Pharma customers in Vacaville, CA
Duration: Ongoing - This is a direct hire position with Kelly Outsourcing & Consulting Group. Position come with medical benefits, paid time off, including vacation, sick time, and holidays. Outsourced roles are not temporary positions.
Process Engineer will write, execute and summarize validation studies required by the 2017 Process Validation Master Plan.
Write, execute and summarize investigational protocols for process validation studies required by 2017 Process Validation Master Plan.
Monitor execution of validation projects and initiatives where required.
Monitoring will require interaction with manufacturing personnel related to study details and procedures and data collection.
Develop, write and maintain SOPs and protocols for processes based on study results.
Verify that procedures are compliant with cGMP requirements.
Supplier personnel will prepare and deliver documentation for review.
Supplier personnel will not approve documentation or determine what procedures become implemented into the manufacturing process.
Participate in change management process if applicable.
Identification of opportunities for improvement within the process or other process areas will be considered in scope but not a core responsibility.
All opportunities will be submitted to client manager for review and entry into the change management system.
Client manager must take primary responsibility for change management while supplier team members may support the process by providing suggestions, data, feedback, documentation or monitoring.
Perform investigations in cases of failures within manufacturing process associated with validation studies defined by plan.
Identify and document root causes and recommend remediation actions.
Assist with monitoring remediation activities if necessary.
BS degree in Engineering or Life Sciences
Strong communication skills verbal and written.
Some technical writing experience is preferred.
Experience working in a GMP environment is preferred.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States.
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 2016 was $5.3 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm