Facilities and Engineering Support Specialist

hace 1 mes


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

We are seeking a highly skilled Facilities and Engineering Support Specialist to join our team at Validation & Engineering Group, Inc. This role will play a crucial part in maintaining the integrity and compliance of our manufacturing facilities.

Responsibilities
  • Documentation Management: Facilitate and manage documentation changes related to facilities and engineering processes, ensuring adherence to regulatory guidelines, internal quality standards, and industry best practices.
  • Pest Control Program Support: Provide support to the pest control program to maintain a pest-free environment within the facility, collaborating with external pest control vendors and internal teams to address and resolve any pest control issues.
  • Deviation and CAPA Management: 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), and monitor and track progress for timely closure and compliance.
  • Change Control: Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities, collaborate with stakeholders to assess impact and ensure proper documentation and implementation, and maintain Change Control records.
Qualifications

To be successful in this role, you will require:

  • A Bachelor's degree in Engineering, Life Sciences, or a related field.
  • A 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 problem-solving skills.
  • Detail-oriented with a focus on quality and compliance.
What We Offer

In addition to a competitive salary, we offer a comprehensive benefits package, opportunities for professional growth and development, and a dynamic work environment.



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