Facilities & Quality Systems Engineer – Life Sciences

Inteldot; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Inteldot, a life sciences-focused organization, seeks a Facilities & Engineering Support Specialist to bolster Quality Systems, CAPA, and Change Controls for manufacturing facilities. You will handle deviations, documentation changes, and pest-control program improvements, collaborating with Quality, F&E, and cross-functional teams.

The role emphasizes regulatory compliance, process improvement, and accurate record-keeping within a highly controlled environment, with potential extended shifts as

Qualifications

• Experience with pharmaceutical/biotech processes.
• Specialized knowledge of industrial chilled water, cooling towers and HVAC systems.
• Familiarity with validation and documentation in a highly regulated environment.
• Deviations and CAPA management capabilities.
• Problem solving to address routine technical problems and drive process improvements.
• Flexibility to work extended shifts and weekends as needed.

Responsibilities

• Provide primary support for Quality Systems activities including deviations, CAPAs, Change Controls and related documentation.
• Investigate deviations from procedures following SOPs and document outcomes.
• Collaborate with Quality and stakeholders to implement CAPAs timely.
• Maintain complete, compliant quality records and inspection readiness.
• Manage documentation changes for facilities and engineering processes.
• Ensure changes meet regulatory guidelines and internal standards.
• Support creation, review, routing and tracking of OEFM electronic forms.
• Ensure OEFM forms are accurate and processed within timelines.
• Coordinate with F&E, Quality and cross-functional teams on form-related questions.
• Advance the Pest Control program and coordinate with vendors and internal teams.
• Document and maintain records for pest control efforts.
• Support Change Control by evaluating proposed changes to facilities, utilities and equipment.
• Assess impact of changes and ensure proper documentation and implementation.
• Maintain Change Control records and assist during regulatory inspections.

Skills

Negotiation

Persuasion

Collaboration

Project cost development

Conflict Resolution

Leadership

Team building

Scheduling & resource loading

Education

Doctorate + 2 years engineering experience OR Master’s + 6 years OR Bachelor’s + 8 years related experience

Job description

Inteldot, a life sciences-focused organization, seeks a Facilities & Engineering Support Specialist to bolster Quality Systems, CAPA, and Change Controls for manufacturing facilities. You will handle deviations, documentation changes, and pest-control program improvements, collaborating with Quality, F&E, and cross-functional teams.

The role emphasizes regulatory compliance, process improvement, and accurate record-keeping within a highly controlled environment, with potential extended shifts as