JT722 - SR. SPECIALIST TECH ENGINEERING

Quality Consulting Group•Juncos, PR

2d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in related area
8 years of directly related experience.
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

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.