Sr. Specialist Tech Engineering 35722

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 has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

First Shift

Job Description:

The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of manufacturing facilities. This role involves providing crucial support in Quality Systems, including deviations, Corrective and Preventive Actions (CAPAs), Change Controls, documentation changes, pest control program management support, and OEFM electronic forms.

Requirements & Qualifications:

• Working knowledge of pharmaceutical/biotech processes.
• Specialized industrial chilled water, cooling towers and HVAC systems expertise.
• Familiarity with validation and documentation processes in a highly regulated environment.
• Deviations and CAPA management capabilities
• Problem solving skills with the ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
• Flexibility to work extended shift and/or weekends as per business needs.
• Skills in the following areas: Negotiation, Persuasion, Collaboration, Project cost development, Conflict Resolution, Leadership, Team building & Schedule and Resources loading development.

Responsibilities:

• Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
• Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
• Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
• Facilitate and manage documentation changes related to facilities and engineering processes.
• Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
• Collaborate with relevant stakeholders to implement documentation changes efficiently.
• Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
• Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
• Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.
• Support the transformation of the Pest Control program into a state of the art program.
• Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
• Support the documentation and records related to the pest control program.
• Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
• Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
• Maintain Change Control records and provide support during regulatory inspections.

Education:

• Doctorate degree and 2 years of Engineering experience OR Master’s degree and 6 years of Engineering experience OR Bachelor’s degree and 8 years of directly related experience