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.
First and second 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:
- Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry
Proficiency in technical report writing. - Effective communication skills in both Spanish and English (verbal and written).
- Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques.
- Strong problem-solving skills and experience conducting root cause investigations.
- Expertise in identifying and managing Corrective and Preventive Actions (CAPAs).
- Proficiency in statistical analysis and Design of Experiments (DOE) methodologies.
- Ability to apply engineering principles to solve technical issues in a production environment.
Responsibilities:
- 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:
- Bachelor’s in engineering + 2 years of Engineering experience
Skills Required
- Bachelor's degree in engineering
- At least 2 years of engineering experience
- Experience in a GMP-regulated pharmaceutical, medical device, or biotechnology environment
- Technical report writing proficiency
- Verbal and written fluency in Spanish and English
- Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques
- Problem-solving and root cause investigation experience
- Experience identifying and managing Corrective and Preventive Actions (CAPAs)
- Proficiency in statistical analysis and Design of Experiments methodologies
- Ability to apply engineering principles in a production environment
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
