ZL01-010424 Sr Specialist Tech Engineering

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr Specialist Tech Engineering

FUNCTIONS:

• 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.
• 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.