Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Non-Standard Shift
Job Description:
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:
- Educational background in Mechanical, Electrical and/or Chemical Engineering
- Statistical Analyses experience
- Experience in Biotech companies would be a plus
- Drug substance manufacturing/technical support would be a plus
Responsibilities:
- Provides engineering support for the operation, troubleshooting, optimization, and modification of HVAC, utilities, and facility systems within a regulated pharmaceutical/biotech environment.
- Applies engineering principles to resolve operational issues, support preventive maintenance strategies, and execute facility modifications and capital projects.
- Work closely with Facilities, Maintenance, Manufacturing, Quality, Validation, EHS, and external engineering and service providers to ensure facility systems operate safely, reliably, efficiently, and in compliance with applicable GMP and regulatory requirements.
- 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.
Education:
- Master degree OR Bachelor degree in Engineering & 2 years of Engineering experience
Skills Required
- Bachelor’s or master’s degree in Engineering
- Bachelor’s degree in Engineering plus 2 years of engineering experience
- Experience with statistical analysis
- Experience in biotechnology companies
- Drug substance manufacturing or technical support experience
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
