Engineer ProQN844

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

Job summary

ProQuality Network seeks an Engineer to support process optimization, troubleshooting, and engineering projects in a highly regulated pharmaceutical/biotechnology setting. The role emphasizes applying engineering principles to operational challenges, system modifications, validation activities, and cross-functional collaboration.

The ideal candidate will hold an engineering degree with strong analytical skills, experience in GLP/GMP contexts, and the ability to manage routine technical tasks

Qualifications

• Engineering background required or preferred with exposure to regulated environments.
• Experience with statistical analysis and data interpretation is desired.
• Familiarity with GLP/GMP and validation processes is advantageous.
• Experience in pharmaceutical/biotechnology operations or support is a plus.

Responsibilities

• Support process optimization and troubleshooting in operations, manufacturing, pilot plant or capital projects.
• Apply engineering principles to support system modifications, experiments and capital projects.
• Analyze data and present clear interpretations and recommendations.
• Provide solutions to technical problems of moderate scope and complexity.
• Collaborate with multiple teams including QA, Validation and Manufacturing to ensure compliant outcomes.
• Assist project managers with design, engineering, and construction projects while maintaining schedule and budget.

Skills

Strong problem-solving

Analytical thinking

Verbal communication

Presentation skills

Time management

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering with 2 years of experience

Tools

Statistical Analysis

Laboratory equipment operation

Computer systems knowledge

Job description

Title: Engineer ProQN844

Location: East of Puerto Rico

Eligibility: Puerto Rico Residents Only

Position: 1 Opening

Work Arrangement: Onsite

Contract: 1 Year

Schedule: Administrative Shift, with availability to support non-standard shifts based on business needs

Position Summary

Our client is seeking an Engineer to support process optimization, troubleshooting, manufacturing operations, and engineering projects within a highly regulated pharmaceutical/biotechnology environment.

The ideal candidate will have an engineering background, strong analytical and problem-solving skills, and the ability to apply engineering principles to operational challenges, system modifications, validation activities, and projects of limited to moderate scope and complexity.

Key Responsibilities

• Support process optimization and troubleshooting activities within operations, manufacturing, pilot plant, or capital project environments.
• Apply engineering principles to support system modifications, experiments, and capital projects.
• Analyze operational and engineering data and present clear interpretations and recommendations.
• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques and procedures under general supervision.
• Complete routine technical assignments and investigations involving a limited number of variables.
• Serve as a technical resource for equipment and systems troubleshooting.
• Support daily operations when needed to meet schedules or resolve complex technical issues.
• Assess the operational performance and regulatory compliance of equipment and systems.
• Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
• Support the development of requirements and recommendations for system modifications.
• Assist project managers with design, engineering, and construction projects while maintaining schedule and budget requirements.
• Collaborate with consultants, architects, and engineering firms on standard design documentation.
• Review and evaluate quotes for equipment modifications or installations.
• Prepare basic project cost estimates and schedules.
• Perform additional functions as assigned based on business needs.

Preferred Qualifications

• Chemical Engineering background preferred.
• Experience with Statistical Analysis.
• Biotechnology industry experience is a plus.
• Experience with Drug Substance Manufacturing or technical support is a plus.
• Working knowledge of pharmaceutical/biotechnology processes.
• Familiarity with validation processes and validation protocol execution.
• Familiarity with documentation requirements in a highly regulated environment.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles to manufacturing operations.
• Experience developing solutions to routine technical problems.
• Ability to operate specialized laboratory equipment and computer systems as required.
• Strong problem-solving and applied engineering skills.
• Basic technical report writing and presentation skills.
• Strong verbal communication skills.
• Strong personal organization and ability to manage change.
• Familiarity with validation protocol writing.
• Strong analytical problem-solving skills and computer literacy.
• Technical knowledge related to equipment and systems.

Education & Experience

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