Senior Technical Specialist

hace 2 semanas


Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

Job Summary:

We are seeking a highly skilled Technical Specialist to join our team at Validation & Engineering Group, Inc. The successful candidate will be responsible for evaluating and optimizing Preventive & Predictive maintenance Job Plans at HVAC/Process Chilled Water & Cooling Towers systems.

Key Responsibilities:

  • Evaluate and optimize Preventive & Predictive maintenance Job Plans at HVAC/Process Chilled Water & Cooling Towers systems.
  • Support Maintenance technical teams on corrective and troubleshooting activities on exposed systems.
  • Align with Corporate and site engineering policies and procedures that impact multiple organizational units.
  • Supervise, coordinate and review work contractors/suppliers on an ongoing basis and on a project basis.
  • 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.

Requirements:

  • 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/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 shifts and/or weekends as per business needs.

Qualifications:

  • Documentation Changes: 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.
  • Pest Control Program: Provide support to the pest control program to maintain a pest-free environment within the facility. Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
  • Deviations and CAPAs: Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs). Work closely with the Quality team to initiate and implement effective Corrective and Preventive Actions (CAPAs).
  • Change Controls: 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.

Available to work extended hours, possibility of weekends and holidays.



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