Title: Engineer

Location: East of Puerto Rico (Open to Puerto Rico Residents)

Positions: 1

Shift: Administrative Shift

Duration: Approximately 5 months

Summary

The Engineer contractor will represent ProQuality Network at our client site by contract. Under general supervision, this role will provide characterization of process optimization strategies and/or troubleshooting of operational issues in operations, manufacturing, pilot plant, or capital project environments. The Engineer will apply engineering principles to the design and implementation of system modifications, experiments, and/or capital projects. The position requires organizing, analyzing, and presenting results related to operational issues or engineering projects of moderate scope and complexity.

Preferred Qualifications & Responsibilities

• Act as equipment owner within the CMMS system, including work order approval, closing, preventive maintenance strategy, and spare parts definition, accuracy, and updates.
• Support reliability and change control assessments and requirements.
• Collaborate with engineering staff to ensure optimal maintenance strategies for manufacturing equipment.
• Enhance system reliability by focusing on equipment availability, downtime reduction, and maintenance optimization.
• Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying performance improvement opportunities.
• Lead and implement equipment improvement projects.
• Serve as SME (Subject Matter Expert) for systems related to design, maintenance, and compliance operations.
• Provide equipment troubleshooting support within the functional area and technical expertise.
• Support deviation investigations and define, implement, and own CAPAs related to equipment.
• Drive Environmental, Health, and Safety (EHS) compliance across the organization.

Functions

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision, with support for unusual problems.
• Perform assignments with clear objectives requiring investigation of limited variables.
• Initiate and complete routine technical tasks.

Operations Engineering

• Act as a technical expert for equipment or systems regarding troubleshooting operations.
• Become actively involved in daily operations when required to meet schedules or resolve complex problems.
• Audit operational performance and regulatory compliance of equipment and systems.
• Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, QA, and validation to develop requirements and recommendations for system modifications.

Design Engineering

• Work under the supervision of project managers to complete design, engineering, and construction projects within scope, schedule, and budget.
• Collaborate with consultants, architects, and engineering firms to develop standard design documents.
• Obtain and evaluate quotes for equipment modifications or installations.
• Generate preliminary project cost estimates and schedules.

Other functions may be assigned as needed.

Education

• Master’s degree in Engineering; OR
• Bachelor’s degree in Engineering with a minimum of 2 years of engineering experience.

Additional Preferred Knowledge, Skills, and Abilities

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes and documentation in regulated environments.
• Ability to operate specialized laboratory equipment and computer systems.
• Strong understanding of GLPs and GMPs.
• Ability to apply engineering science to production.
• Capable of developing solutions to technical problems of limited scope.
• Demonstrated skills in:
• Problem solving and applied engineering
• Technical report writing and presentations
• Validation protocol execution and writing
• Managing change in regulated environments
• Equipment-specific technical expertise
• Analytical problem-solving
• Computer literacy
• Personal organization and time management

We invite prospective candidates who meet these qualifications to apply through the job description link and submit an updated resume for evaluation.