Engineer 35737

Inteldot; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Inteldot seeks a qualified engineer to optimize manufacturing processes in a GMP-regulated setting. Responsibilities include solving technical issues, conducting root cause analyses, and supporting CAPA and DOE activities across packaging and production lines.

The role emphasizes collaboration with QA, validation, and maintenance teams, along with training and equipment qualifications. Strong English/Spanish communication is required.

Qualifications

• Experience in GMP-regulated pharma/medical device/biotech environments.
• Proficiency in technical report writing.
• Bilingual in Spanish and English (verbal and written).
• Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques.
• Strong problem-solving skills and experience with root cause investigations.
• Expertise in CAPA identification and management.
• Proficiency in statistical analysis and DOE methodologies.
• Ability to apply engineering principles to solve production issues.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Act as a technical expert during troubleshooting and cross-functional discussions.
• Frequently engage in daily operations to meet schedules and resolve complex issues.
• Routinely supervise manufacturing processes for KPIs and mentor troubleshooting.
• Collaborate with manufacturing, maintenance, process development, QA, validation to define requirements for modifications.
• Support deviations, equipment qualification, process validation, procedures, training, and new product introductions.
• Apply engineering, scientific, and analytical skills to support manufacturing operations.
• Organize, analyze, and present results for operational issues or projects of moderate scope and complexity.
• Support 7/24 non-standard shift operation including extended hours and weekends as needed.

Skills

Report writing

Spanish/English bilingual

Packaging equipment

Root cause analysis

CAPA management

DOE methodologies

Statistical analysis

Engineering problem solving

Education

Bachelor's in engineering + 2 years of experience

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.

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