Process Engineer 2

Process Engineer || Irvine, CA- Hybrid || Fulltime
Primary Skills
NPD, NPI, Process & product development, Process and Equipment Validation, Process Characterization, good manufacturing practices and documentation, Process Improvement
Job Description
Must Have Technical/Functional Skills
• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs
• Knowledge in Experiment design and SPC
• Management of statistical procedures
• Strong creative, analytical and problem-solving skills.
• Comprehension of standard costs and work standards
• Proficient at interpreting data and putting that data into a report
• Experience in PLM Tool (Windchill)
• Process experience, ability to observe and understand manufacturing processes
• Excellent Interpersonal / communication skills, Organizational / planning skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Roles & Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are:
• Identifies, designs and develops the necessary equipment related to new product development/new product introduction.
• Performs material tests.
• Studies the existing processes to plan and implement improvements.
• Responsible for preparing and managing specifications.
• Assists technicians and engineers about unusual problems.
• Responsible for purchasing and designing equipment that meets safety and environment requirements.
• Perform Process Development, Tool Development activities
• Performs activities of process/product/ Equipment validation.
• Creation of ECOs to upload documentation changes to PLM system (Windchill) as per the requirement.
• Can supervise, coordinate and technically revise the work of a limited group of technicians
• Know & follow policies & procedures related to work activities performed in area of responsibility
• Complete training in area of responsibility within allowed time-period and periodic retraining in areas
Generic Managerial Skills, If any
• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Ability to function in a team environment and deliver on team objectives is required.
• Ability to make decisions and solve problems while exhibiting situational judgement.
Desired Skills : PLM | Windchill
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.