Engineer 35685

Inteldot; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Inteldot seeks a process engineering professional for a 3rd shift role in Puerto Rico. Under supervision, you will apply basic engineering principles to optimize manufacturing processes in a GMP environment and assist in system modifications and troubleshooting.

You will analyze results, prepare technical reports in both Spanish and English, and collaborate with manufacturing, QA, and validation teams to drive CAPAs and process improvements while supporting extended hours as needed.

Qualifications

• Experience in GMP-regulated pharma/biotech/medical device industries.
• Bilingual in Spanish and English (verbal and written).
• Master or Bachelor in Engineering with 2+ years engineering experience.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Act as a technical expert in troubleshooting operations and equipment.
• Routinely supervise manufacturing processes for performance indicators.
• Collaborate with QA, maintenance, process development, utilities, facilities and validation.
• Support deviations, equipment qualification and process validation, procedures and training.
• Apply engineering principles to system modifications and capital projects.
• Support 7/24 non-standard shift operation as needed.

Skills

CAPA management

DOE methodologies

Root cause analysis

GMP environment

Bilingual Spanish/English

Technical report writing

Process optimization

Education

Engineering degree

Job description

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 (Support 7/24 non-standard shift operation including extended hours and weekends as per business needs. Position will be for 3rd 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

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