Title: Engineer 35544 – Biotechnology Industry

Location: Juncos, Puerto Rico (Only for Puerto Rico residents)

Position: 1 Opening

Schedule: 1st Shift (8-hour shift)

Contract: 1 Year

Position Summary

Our client is seeking an Engineer to support engineering activities within a regulated biotechnology manufacturing environment. This role is responsible for providing technical support for process optimization, operational troubleshooting, equipment and system improvements, and engineering projects. The selected candidate will apply engineering principles to evaluate manufacturing processes, implement system modifications, support validation activities, and collaborate with cross-functional teams to ensure safe, compliant, and efficient operations.

This position also supports equipment and system decommissioning projects, technical documentation, change control activities, and continuous improvement initiatives while maintaining compliance with GMP and regulatory requirements.

Key Responsibilities

• Provide technical support to manufacturing operations by troubleshooting equipment and process-related issues.
• Evaluate, select, and apply standard engineering techniques to resolve routine and moderately complex technical challenges.
• Support process optimization and operational improvements to enhance manufacturing performance.
• Participate in equipment and system decommissioning activities within a regulated manufacturing environment.
• Perform engineering assessments and investigations to identify and implement effective technical solutions.
• Support validation activities, including protocol execution and documentation.
• Collaborate with Engineering, Manufacturing, Maintenance, Quality, Validation, Utilities, Facilities, and Process Development teams on system modifications and improvement projects.
• Monitor equipment performance and support regulatory compliance through routine engineering evaluations.
• Assist in change control activities, risk assessments, impact assessments, and asset lifecycle management.
• Coordinate technical documentation, engineering records, and project deliverables.
• Support engineering design, construction, and equipment modification projects while meeting established timelines and project objectives.
• Work with vendors, consultants, and engineering firms to develop design documentation and obtain quotations for equipment modifications or installations.
• Prepare basic project schedules, cost estimates, technical reports, and engineering presentations.
• Drive continuous improvement initiatives to increase equipment reliability and operational efficiency.
• Perform additional engineering duties as assigned.

Preferred Qualifications

• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment.
• Familiarity with commissioning, decommissioning, validation processes, and validation protocol execution.
• Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
• Experience with change control processes, risk assessments, and regulatory compliance.
• Knowledge of asset lifecycle management.
• Ability to troubleshoot technical and operational issues using sound engineering principles.
• Experience coordinating cross-functional teams and collaborating with Engineering, Manufacturing, Operations, Maintenance, Quality, Validation, Utilities, and Process Development.
• Strong technical documentation and report writing skills.
• Excellent analytical, organizational, planning, and project management skills.
• Effective verbal and written communication skills.
• Ability to manage multiple priorities and meet project deadlines.
• Strong computer literacy and experience working in highly regulated environments.
• Self-motivated, detail-oriented, and proactive with a continuous improvement mindset.

Minimum Education & Experience

Candidates must meet one of the following requirements:

• Master's Degree in Engineering, or
• Bachelor's Degree in Engineering with at least two (2) years of engineering experience in a manufacturing or regulated industry.