erience 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
Provide technical engineering support to continuous daily operations by performing troubleshooting activities, process optimization strategies,
upgrades, replacements, and modifications to the process or equipment in the manufacturing operations.
Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.
This role will support non-standard shift manufacturing operations that may nights and weekends.
Specific responsibilities include but are not limited to:
• 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.
Requirements
Skills Required
- Master or Bachelor degree in Engineering
- 2 years of Engineering experience
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
