Senior QA Engineer ProQN722

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Our Client is seeking a Senior QA Engineer to provide and direct process optimization strategies and troubleshoot operational issues associated with site utilities, HVAC systems, cooling towers, and chilled water distribution.

The role will apply advanced engineering and maintenance principles to major system modifications, experiments, process improvements, and capital projects, serving as a key contributor within the Facilities and Engineering organization.

Qualifications

• Engineering degree and 8+ years hands-on experience in facilities and quality engineering.
• Strong knowledge of Quality Systems, deviations, CAPA, Change Controls, and controlled documentation.
• Experience with OEFM electronic forms or similar electronic quality/facilities-management systems.

Responsibilities

• Provide primary support for Quality Systems activities including deviations, CAPAs, Change Controls and related quality documentation.
• Investigate and document deviations from procedures in accordance with SOPs.
• Collaborate to initiate, implement, monitor, and close effective CAPAs within timelines.
• Ensure Quality Systems records are complete, accurate, and inspection-ready.
• Facilitate and manage documentation changes for Facilities and Engineering processes.
• Support creation, review, routing, and tracking of OEFM electronic forms.

Skills

Quality Systems

OEFM electronic forms

Pest control programs

FDA regulatory knowledge

Deviations and CAPA management

Change Controls

Documentation management

Education

Engineering degree

Job description

Our Client is seeking a Senior QA Engineer to provide and/or direct process optimization strategies and troubleshoot operational issues associated with site utilities, HVAC systems, cooling towers, and chilled water distribution. The candidate should have Engineering degree with 8+ years hands on experience inside facilities and quality engineering areas.

This role will apply advanced engineering and maintenance principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. The selected professional will serve as a key individual contributor within the Facilities and Engineering organization, supporting the site’s engineering and operational objectives.

Preferred Qualifications

• Strong knowledge and demonstrated experience with Quality Systems, particularly deviations, CAPA management, Change Controls, and controlled documentation.
• Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems.
• Understanding of pest control programs within a regulated manufacturing environment.
• Knowledge of regulatory requirements, including FDA and other applicable regulatory authorities.
• Excellent organizational, communication, problem-solving, and analytical skills.
• Detail-oriented approach with a strong focus on quality, compliance, and timely execution.

Position Overview

The Senior QA Engineer will contribute to maintaining the integrity, compliance, and operational effectiveness of Facilities and Engineering activities. The role will provide support in Quality Systems, deviations, CAPAs, Change Controls, documentation changes, pest control program management, and OEFM electronic forms, while also supporting engineering activities related to HVAC, cooling towers, and chilled water systems.

Key Responsibilities

Quality Systems

• 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 in accordance with applicable SOPs.
• Collaborate with Quality and cross-functional stakeholders to initiate, implement, monitor, and close effective CAPAs within established timelines.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.

Documentation Changes

• Facilitate and manage documentation changes associated with Facilities and Engineering processes.
• Ensure documentation changes comply with regulatory requirements, internal quality standards, and applicable industry practices.
• Collaborate with stakeholders to implement documentation changes efficiently and accurately.

OEFM Electronic Forms

• Support the creation, completion, review, routing, and tracking of OEFM electronic forms.
• Ensure forms are completed accurately and maintained in accordance with applicable procedures and timelines.
• Collaborate with Facilities & Engineering, Quality, and other cross-functional teams to resolve form-related questions or issues.

Pest Control Program

• Support the transformation and continuous improvement of the site’s Pest Control program.
• Collaborate with external pest control vendors and internal teams to address and resolve pest control issues.
• Support the maintenance of documentation and records associated with the program.

Change Controls

• Support the Change Control process for proposed changes involving facilities, utilities, equipment, and critical utility systems.
• Collaborate with stakeholders to assess change impacts and ensure appropriate documentation and implementation.
• Maintain Change Control records and provide support during regulatory inspections.

Engineering & Technical Functions

• Evaluate and optimize Preventive and Predictive Maintenance Job Plans for HVAC, process chilled water, and cooling tower systems.
• Provide technical support to Maintenance teams during corrective maintenance and troubleshooting activities involving these systems.
• Ensure alignment with corporate and site engineering policies and procedures affecting multiple organizational units.
• Supervise, coordinate, and review contractor and supplier work on both ongoing operations and project-based activities.
• Serve as a recognized technical resource for chilled water, cooling towers, and HVAC systems, including determining appropriate methodologies and approaches.
• Promote a culture of problem-solving and continuous improvement.
• Collaborate with Project Managers to execute design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate consultants, architects, and engineering firms involved in developing standard design documentation.
• Develop technical solutions to complex problems using ingenuity, innovation, and sound engineering judgment.

Education & Experience

• 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.
• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Specialized expertise in industrial chilled water, cooling towers, and HVAC systems.
• Familiarity with validation and documentation processes within highly regulated environments.
• Experience with deviation and CAPA management.
• Strong problem-solving skills and the ability to develop solutions to technical problems and apply engineering principles to process improvements and troubleshooting.
• Ability to work extended shifts and/or weekends based on business needs.