Adecco Engineering & Technical has an immediate contract position for an Equipment Validation Engineer in Canoga Park, CA. This contract position is scheduled for up to 12 months with our client who is a global leader in servicing science, laboratory and patient diagnostics.
Title: Equipment Validation Engineer
Location: Canoga Park, CA.
Pay rate: $40 - $43/hr
Length: up to 12 months
Writing, executing, and reporting validation protocols and other relevant documentation. Protocols include User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), equipment validation and process validation in support of products and processes at TDX. Additional responsibilities in the areas of process engineering and improvement, interfacing with Research & Development and Manufacturing. The engineer will also interface with Operations, Quality, and Operations Excellence.
Coordinate and perform validation projects and protocols in support of equipment, product, process and cleaning validation.
Write and review protocols and reports.
Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
Collaborate with R&D to ensure successful process development and technical transfer to Operations.
Coordinate validation activities in support of assigned validation projects working closely with Quality Engineering, Engineering team members, Operations Excellence, Operations, etc.
Recommend approval or failure of validation reports.
Provide support to Engineering to ensure protocols are executed as intended.
Maintain knowledge and comprehensive understanding of relevant Medical Device / pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation.
Be a resource to other departments for product and process knowledge.
Works with Operations Excellence, Operations & Quality to drive efficiency and implement future state processes.
Participant in our PPI Lean Enterprise initiatives driving improvements through customer delivery & improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.
Provide technical skills for Kaizen events and other Lean initiatives.
Completes process validations.
Performs root cause analysis and suggest workarounds and/or solutions for recurring issues.
Promote a collaborative Team environment that fosters creativity, innovation and high performance.
Bachelor’s degree in Engineering or Science Field.
An advanced degree such as an MBA is a plus. PM certification is a plus.
Five years relevant experience in medical device or pharmaceutical arena.
Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation systems.
Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
Strong project management and organizational skills.
Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
Excellent verbal and written communication skills.
Previous experience in problem solving methodology.
Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
Must be able to travel as needed.
If you are interested in this Equipment Validation Engineer contract position in Canoga Park, CA then please click ‘APPLY NOW’. For other opportunities available at Adecco Engineering and Technical go to www.adeccousa.com. If you have questions about the position please contact Sri Tirumala at (626) 463-2332 or email@example.com .
Equal Opportunity Employer Minorities/Women/Veterans/Disabled