Title: Engineer

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

Positions: 1

Shift: Non-Standard Shift (including nights and weekends as needed)

Duration: Approximately 6 months

Summary

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

Preferred Qualifications

The Engineer will provide technical engineering support to daily manufacturing operations, with emphasis on troubleshooting, process optimization, upgrades, replacements, and modifications of processes or equipment. Additional responsibilities include:

• Ensuring operations are accomplished in compliance with corporate policies, industry standards, and regulatory requirements.
• Supporting non-standard shift manufacturing operations, which may include nights and weekends.

Key Responsibilities

General Engineering Functions

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

Operations Engineering

• Function as a technical expert for processes, equipment, and/or systems during troubleshooting and cross-functional discussions.
• Actively participate in daily operations to meet schedules or resolve complex problems as needed.
• Routinely monitor manufacturing processes for performance indicators and compliance.
• Recommend corrective actions and provide troubleshooting guidance.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for process or system modifications.
• Support the execution of manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and new product introductions.
• Apply process, operational, and scientific expertise, compliance knowledge, and analytical skills to support manufacturing operations.

Design Engineering

• Support project managers in completing design, engineering, and construction projects within scope, schedule, and budget.
• Collaborate with consultants, architects, and engineering firms to develop standard design documents.
• Obtain and review quotes for equipment modifications or installations.
• Generate preliminary project cost estimates and schedules.

Additional Functions

• Support 24/7 non-standard shift operations, including extended hours and weekends, based on business needs.
• Perform other duties as assigned.

Education

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

Preferred Knowledge, Skills, and Abilities

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

Prospective Candidates may apply inside the job description link with an updated resume for evaluation.