Sr Specialist Tech Engineering

• 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 to the pest control program to maintain a pestfree 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.
  

• 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.
  

• 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.
  

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
  (Engineering)
  
• Strong understanding of documentation control pest control programs deviations/CAPA management and Change Controls.
  
• Knowledge of regulatory requirements including FDA and other relevant authorities.
  
• Excellent organizational communication and problemsolving skills.
  
• Detailoriented with a focus on quality and compliance.
  
• Bilingual (Spanish/English)(Speak/Write)
  
• Computer Literacy