Senior Engineer - Pharma Manufacturing & Process Optimization

ProQuality Network; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, seeks a Senior Engineer to lead process optimization, troubleshooting, and capital projects across operations and manufacturing environments. You will apply advanced engineering principles to design modifications, perform experiments, and communicate complex results to stakeholders.

The role requires strong knowledge of pharmaceutical/biotech operations, GMP/GLP familiarity, and robust project leadership.

Qualifications

• Working knowledge of pharmaceutical and/or biotechnology manufacturing processes.
• Familiarity with equipment and process validation.
• Experience with technical documentation in highly regulated environments.
• Ability to operate specialized laboratory or manufacturing equipment and use relevant computer systems.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles and scientific knowledge to manufacturing and production environments.
• Ability to develop solutions to routine technical problems within defined scope.
• Strong problem-solving and applied engineering skills.
• Basic technical report-writing skills.
• Strong verbal and written communication skills.
• Understanding of validation protocol execution requirements.
• Ability to prepare and support validation protocols and related documentation.
• Strong organizational and time-management skills.
• Ability to adapt to changing priorities and manage multiple projects simultaneously.
• Ability to independently identify when additional internal or external resources are required to resolve technical issues.
• Ability to interact effectively with individuals across different communication and working styles.
• Technical expertise with specialized equipment and processes.
• Knowledge of validation requirements associated with new equipment installations.
• Ability to apply analytical and scientific problem-solving techniques to develop hypotheses, evaluate alternatives, and determine appropriate engineering approaches.
• Working knowledge of financial analysis and project cost-development tools.
• Ability to delegate responsibilities and effectively manage the project work of others.

Responsibilities

• Lead and/or direct process optimization and engineering projects within operations, manufacturing, pilot plant, and capital projects.
• Develop and communicate technical results for operational issues and complex projects.
• Design and implement major system modifications and experiments to improve efficiency and quality.
• Collaborate with multiple teams to establish requirements and recommendations for large-scale modifications.
• Coordinate budgets and manage project scope, schedule, and quality.

Skills

Pharma manufacturing

Biotech manufacturing

Validation

Technical documentation

Analytical problem solving

Report writing

Communication skills

Validation protocols

Project management

Leadership

Cross-functional collaboration

Education

PhD in Engineering

MS in Engineering + 2+ years experience

BS in Engineering + 4+ years experience

Job description

ProQuality Network in Juncos, Puerto Rico, seeks a Senior Engineer to lead process optimization, troubleshooting, and capital projects across operations and manufacturing environments. You will apply advanced engineering principles to design modifications, perform experiments, and communicate complex results to stakeholders.

The role requires strong knowledge of pharmaceutical/biotech operations, GMP/GLP familiarity, and robust project leadership.