Sr Specialist Tech Engineering

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 95,000 - 135,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a Senior Specialist Technical Engineering to lead optimization and troubleshooting for site utilities, HVAC, cooling towers, and chilled water. You will design major system modifications and manage capital projects with adherence to quality systems.

Role requires extensive regulatory knowledge, CAPA/change control experience, and ability to coordinate with external vendors. 1‑year contract, first shift, on‑site in Juncos, Puerto Rico.

Qualifications

• Requires strong knowledge of Quality Systems: deviations, CAPA, change controls, and controlled documentation.
• Experience supporting OEFM electronic forms or similar electronic quality/facilities management systems.
• Knowledge of regulatory requirements (FDA and others).
• Detail‑oriented with focus on quality, compliance, and timely execution.

Responsibilities

• Evaluate and optimize preventive & predictive maintenance for HVAC, process chilled water, and cooling towers.
• Support maintenance teams with corrective actions and troubleshooting.
• Coordinate with stakeholders to implement design documents and capital projects.
• Lead deviations, CAPAs, change controls, and related quality documentation.
• Collaborate with Quality and cross‑functional teams to resolve form‑related issues.
• Provide primary support for pest control program documentation and electronic forms.

Skills

pharmaceutical processes

industrial chilled water systems

validation/documentation

deviations/CAPA management

problem solving

extended shifts/weekends

negotiation/collaboration

Education

Doctorate + 2 years

Master’s + 6 years

Bachelor’s + 8 years

Job description

The Senior Specialist Technical Engineering role provides and/or directs process optimization strategies and troubleshooting of operational issues related to site utilities operations, HVAC systems, cooling towers, and chilled water distribution. Applies advanced and diverse maintenance and engineering principles to design and implement major system modifications, experiments, and process/capital projects. This role is a key individual contributor within Facilities &E and manufacturing facilities. This role provides essential support in Quality Systems, documentation changes, pest control program management, and OEFM electronic forms.

Functions

• Evaluate and optimize Preventive & Predictive Maintenance job plans for HVAC, Process Chilled Water, and Cooling Tower systems.
• Support maintenance technical teams with corrective actions and troubleshooting activities for the above systems.
• Align with corporate and site engineering policies and procedures impacting multiple organizational units.
• Serve as a peer‑recognized technical expert in chilled water, cooling towers, and HVAC systems, with responsibility for determining methodologies in these areas.
• Operate under a culture of problem solving and continuous improvement.
• Develop technical solutions to complex problems using ingenuity, innovation, and creativity.
• Supervise, coordinate, and review work performed by contractors and suppliers on an ongoing and project basis.
• Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
• Coordinate work of consultants, architects, and engineering firms in developing standard design documents.

Skills

• Working knowledge of pharmaceutical/biotech processes.
• Specialized expertise in industrial chilled water, cooling towers, and HVAC systems.
• Familiarity with validation and documentation processes in highly regulated environments.
• Deviations and CAPA management capabilities.
• Strong problem‑solving skills with ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
• Flexibility to work extended shifts and/or weekends as needed.
• Skills in negotiation, persuasion, collaboration, project cost development, conflict resolution, leadership, team building, and schedule/resource loading development.

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

Preferred Qualifications (must have)

• Strong knowledge and demonstrated experience with Quality Systems: deviations, CAPA management, change controls, and controlled documentation.
• Experience supporting OEFM electronic forms or similar electronic quality/facilities management systems.
• Understanding of pest control programs within regulated manufacturing environments.
• Knowledge of regulatory requirements, including FDA and other authorities.
• Detail‑oriented with strong focus on quality, compliance, and timely execution.
• Provide primary support for deviations, CAPAs, change controls, and related quality documentation.
• Investigate and document deviations per SOPs.
• Work with Quality and stakeholders to initiate, implement, monitor, and close CAPAs.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection‑ready.
• Facilitate and manage documentation changes related to facilities and engineering processes.
• Ensure documentation changes meet regulatory guidelines, internal standards, and industry best practices.
• Collaborate with stakeholders to implement documentation changes efficiently.
• Support creation, completion, review, routing, and tracking of OEFM electronic forms.
• Ensure forms are completed accurately and processed within required timelines.
• Collaborate with F&E, Quality, and cross‑functional teams to resolve form‑related issues.
• Support transformation of the pest control program into a state‑of‑the‑art system.
• Collaborate with external vendors and internal teams to resolve pest control issues.
• Support documentation and record‑keeping for the pest control program.
• Support evaluation of proposed changes to facilities, utilities, equipment, and critical utilities.
• Collaborate with stakeholders to assess impact and ensure proper documentation and implementation.
• Maintain change control records and support regulatory inspections.

• 1- year contract with possible extension

• First shift.