Engineer

PRPDG; Puerto Rico; On-site; USD 70,000 - 100,000; Full time

Job summary

PRPDG is seeking an engineering professional to optimize processes and troubleshoot operations in a regulated pharma environment. Under general supervision, you will apply basic engineering principles to design and implement system modifications for minor projects and proofs of concept.

The role requires a Bachelor’s or Master’s in engineering with 2+ years of experience in mechanical, electrical, or chemical disciplines, and proficiency in English and Spanish for cross-functional communication.

Qualifications

• 3+ years of engineering-related experience in mechanical, electrical, or chemical disciplines is advantageous.
• Experience in regulated environments and GMP production operations preferred.
• Strong written and verbal communication skills in English and Spanish.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity under general supervision.
• Evaluate and apply standard engineering techniques to design/modify systems or processes.
• Serve as technical expert during troubleshooting with multi-functional teams.
• Support manufacturing/quality systems such as deviations, equipment qualification, and process validation.
• Assist with 7/24 shift operations as needed.

Skills

Troubleshooting

Technical writing

Bilingual English/Spanish

Cross-functional collaboration

Education

Engineering degree (Bachelor's or Master's)

Job description

SUMMARY

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

REQUIREMENTS

• Masters OR Bachelor's in engineering + 2 years of Engineering experience.
• 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
• Specific responsibilities include but are not limited to:
  - 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.
• Available for 5am and 5pm shift. 2/3/2 days shift Example: Week 1: ( Mon-Tues (12hrs shift)) / Fri-Sat-Sun (12 hrs shift)___Week 2: Wed-Thurs( 12 hrs shift)