The Role
Supports pharmaceutical and biotech facilities engineering and quality systems. Manages deviations, CAPAs, change controls, documentation, electronic forms, pest control programs, and inspection readiness. Provides technical expertise for HVAC, chilled water, and cooling tower systems, including preventive and predictive maintenance optimization and troubleshooting. Coordinates engineering projects, consultants, architects, and design documentation while driving compliance, problem solving, and continuous improvement.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly dynamic, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Responsibilities:
- Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of F&E and AML 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.
- 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.
- Evaluate and optimize Preventive & Predictive maintenance Job Plans at the HVAC/Process Chilled Water & Cooling Towers systems.
- Support Maintenance technical teams on the corrective and troubleshooting activities on the exposed systems above.
- Serves as a peer recognized as technical expert in the area of chilled water, cooling towers and HVAC, with overall responsibility for determining methodologies in that area.
- Operate under a culture of problem solving and continuous improvement.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
- Bachelor’s degree in related area
- 8 years of directly related experience.
- Working knowledge of pharmaceutical/biotech processes.
- Experience with Quality Systems, particularly deviations, CAPA management, Change Controls, and controlled documentation.
- 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.
- First shift.
Skills Required
- Bachelor's degree in a related area
- 8 years of directly related experience
- Working knowledge of pharmaceutical or biotechnology processes
- Expertise in industrial chilled water, cooling tower, and HVAC systems
- Familiarity with validation and documentation processes in highly regulated environments
- Deviation and CAPA management capabilities
- Problem-solving skills and ability to apply engineering science to troubleshooting and process improvements
- Ability to work extended shifts and/or weekends as needed
- Negotiation, persuasion, collaboration, conflict resolution, leadership, and team-building skills
- Project cost development and schedule and resource loading development skills
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
