Engineer 35388

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in manufacturing. Apply basic engineering principles to the design and implementation of system modifications. Organize, analyze and present interpretation of results for operational issues or engineering projects of minor scope and complexity.

Requirements:

• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Organizational & technical writing skills
• Proficient presentation & communication skills in English and Spanish
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope

• →Provide solutions to a variety of technical problems of moderate scope and complexity.
• →Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures.
• →Assistance given for unusual problems
• →Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
• →Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
• →Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
• →Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
• →Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
• →Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• →Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
• →Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
• →Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.

• Master degree OR Bachelor degree in Engineering & 2 years of Engineering experience