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Senior Technical Specialist
hace 2 meses
We are seeking a highly skilled Senior Technical Specialist - Engineering 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 the HVAC/Process Chilled Water & Cooling Towers systems. Additionally, they will support Maintenance technical teams on corrective and troubleshooting activities on the exposed systems above. The ideal candidate will have a strong background in engineering, with experience in chilled water, cooling towers, and HVAC systems. They will also possess excellent problem-solving skills, with the ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
Key Responsibilities:
- Evaluate and optimize Preventive & Predictive maintenance Job Plans at the HVAC/Process Chilled Water & Cooling Towers systems.
- Support Maintenance technical teams on corrective and troubleshooting activities on the exposed systems above.
- Align within Corporate and site engineering policies and procedures that impact multiple organizational units.
- Supervise, coordinate and review work contractors/suppliers on an ongoing basis as well as on a project basis.
- 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.
- Develop technical solutions to complex problems using ingenuity, innovation and creativity.
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 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.
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. Collaborate with relevant stakeholders to implement documentation changes efficiently.
- 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. Support the documentation and records related to the pest control program.
- 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). Monitor and track the progress of Deviations and CAPAs, ensuring timely closure and compliance.
- 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. Maintain Change Control records and provide support during regulatory inspections.
- Available to work extended hours, possibility of weekends and holidays.
