View all jobs

Sr Specialist Tech Engineering - 35722

  • Juncos, PR
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary
The Sr Specialist Tech Engineering is responsible for providing technical and quality systems support to Facilities & Engineering (F&E) and AML manufacturing operations, ensuring compliance with regulatory requirements, internal procedures, and quality standards. This role serves as a key contributor in the management of deviations, CAPAs, Change Controls, controlled documentation, OEFM electronic forms, and pest control program initiatives. The position supports continuous improvement efforts to maintain facility integrity, operational excellence, and inspection readiness within a regulated manufacturing environment.

Key Responsibilities
1. Quality Systems:
    1. Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
    2. Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
    3. Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
    4. Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
  2. Documentation Changes:
    1. Facilitate and manage documentation changes related to facilities and engineering processes.
    2. Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
    3. Collaborate with relevant stakeholders to implement documentation changes efficiently.
  3. OEFM Electronic Forms:
    1. Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
    2. Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
    3. Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.
  4. Pest Control Program:
    1. Support the transformation of the Pest Control program into a state of the art program.
    2. Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
    3. Support the documentation and records related to the pest control programs.
  5. Change Controls:
    1. Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
    2. Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
    3. Maintain Change Control records and provide support during regulatory inspections.
Work Schedule
  • First Shift
Minimum Qualifications
  • 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 Engineering experience.

Preferred Qualifications
  • Strong knowledge and demonstrated experience with Quality Systems, including deviations, CAPA management, Change Controls, and controlled documentation.
  • Experience supporting OEFM electronic forms or similar electronic quality and facilities management systems.
  • Understanding of pest control programs within regulated manufacturing environments.
  • Knowledge of FDA regulations and other applicable regulatory requirements.
  • Excellent organizational, communication, and problem-solving skills.
  • Strong attention to detail with a focus on quality, compliance, and timely execution.
  • Ability to work effectively in cross-functional teams and manage multiple priorities.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.