Engineer 35786

Inteldot; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot is seeking an engineering professional to characterize process optimization strategies and troubleshoot manufacturing operations. The role applies basic engineering principles to system modifications and supports cross-functional teams in Puerto Rico and the United States.

The ideal candidate holds a Master’s or Bachelor’s in Engineering, with GMP knowledge and hands-on experience in regulated environments, and is fluent in English and Spanish to communicate with diverse teams across

Qualifications

• Engineering degree in Mechanical, Electrical, or Chemical fields.
• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech GMP processes and operations.
• Strong organizational and technical writing skills.
• Proficiency in presenting and communicating in English and Spanish.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity under supervision.
• Act as technical expert in process, equipment, or systems during troubleshooting and cross-functional discussions.
• Engage in daily/regular operations to meet schedules and resolve issues.
• Supervise manufacturing processes for performance indicators and mentor on troubleshooting.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA, and validation to define requirements for modifications.
• Support manufacturing/quality systems like deviations, equipment qualification, and process validation.
• Apply engineering principles to design and implement system modifications, experiments, and capital projects.
• Support 7/24 non-standard shift operation including extended hours and weekends.

Skills

Mechanical Engineering

Electrical Engineering

Chemical Engineering

GMP Knowledge

Bilingual English/Spanish

Technical Writing

Education

Master's degree in Engineering

Bachelor's degree in Engineering

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

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
• 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.

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