The Role
Provide engineering support for pharmaceutical/biotech manufacturing: troubleshoot equipment and processes, supervise production performance, develop process modifications, support validations, deviations, qualifications, and new product introductions. Collaborate with cross-functional teams and work non-standard shifts as needed.
Summary Generated by Built In
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
Masters OR Bachelor’s in engineering + 2 years of Engineering experience.
• Educational background in Mechanical, Electrical and/or Chemical Engineering
• 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
Skills Required
- Masters OR Bachelor's in engineering plus 2 years of engineering experience.
- Degree background in Mechanical, Electrical, or Chemical Engineering.
- Experience with equipment and/or process troubleshooting in a regulated environment.
- Knowledge of pharmaceutical/biotech processes and GMP production operations.
- Experience supporting deviations, equipment qualification, process validation, procedures, training, and new product introductions.
- Organizational and technical writing skills.
- Proficient presentation and communication skills in English and Spanish.
- Ability to support 24/7 non-standard shift operations including extended hours and weekends.
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
