Eastridge Workforce Solutions is urgently hiring a Process Engineer for a leading pharmaceutical contract manufacturing facility located in the greater Irvine area. The individual will support assignments from the Director of Engineering and Operations Manager - Manufacturing department, providing support to manufacturing operations and developing solutions and processes that meet GMP/ISO 9000 requirements. Qualified candidates interested in this contract role are encouraged to apply.

Responsibilities

• Provide support to projects /tasks/activities in developing equipment and processes that are competitive and meet all GMP and ISO requirements. Emphasis on manufacturing facility, processes, and equipment optimization and improvements.
• Identify potential manufacturing process or equipment improvements to investigate, and develop efficient manufacturing methods and troubleshoot manufacturing stoppage issues
• Track the performance of process equipment or products by gathering data.  Manipulate and analyze data using standard techniques. Makes recommendations and implements solutions.
• Develop equipment specifications and standards for operating procedures
• Stimulate process and product models for evaluation, improvements and enhancements.
• Reads, interprets, and revises process and product blueprints and documentation as required to perform tasks.
• Enter data generated through various tests into computer software (ex. Excel, Word) and perform analysis and create graphs and tables to analyze test results.
• Develop and manage CAD and solid works files for process and component design
• Interface with technicians and suppliers providing technical support as needed.
• Review historical data of existing process equipment or product performance on a regularly scheduled basis.
• Assists in transferring manufacturing processes to the production floor.
• Troubleshoot and resolve problems with the process equipment and fixtures
• Conceptualize and sketch process/product improvement fixtures. Coordinate the development and fabrication of these fixtures.
• Document and maintain records of all assignment activities in a laboratory notebook, for future reference and to comply with SOP’s, GMP’s and regulatory requirements.
• Communicate both in written and e-mail formats
• Modify existing specifications to describe new equipment and fixture capabilities to assist technicians and engineers in operating and testing them.
• Create and update protocols to establish and document processes and procedures using established company software packages. Write and execute protocols and reports as required for process systems and equipment validation
• Interpret and follow test protocols to generate data needed to assess the process or product’s reliability.
• Write Change Notices (CN’s) to change or modify existing documents, processes, or methods to problem-solve or accommodate changes in procedures.
• Prepare reports or summaries (e.g., describe data, problems, conclusions) to inform the supervisor and management of project status

 Required Knowledge, Skills, and Abilities

•  Some knowledge of technical tools i.e. SPC, DOE, PM
• Ability to function well in a team environment
• Strong Oral and written communication skills
• Superior analytical skills and computer skills
• Must be capable of using good reason and judgment to make and defend recommendations
• Demonstrated hands-on technical ability.

 Required Education and Experience

•  Bachelor of Science Degree in Mechanical and or Chemical Engineering 
• Aseptic Processing 
• 2-4 years of pharmaceutical industry experience

Benefits: Use this link bit.ly/2023-Benefits to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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