C&Q Specialist

mîrus Consulting Group View all jobs

  • Manatí, PR
  • Permanent
  • Full-time
  • 19 days ago
mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.Minimum Qualifications & Requirements
All skill sets required to successfully execute the scope of work will be provided. However, the selected resource must demonstrate a strong foundational knowledge in mechanical systems, electrical systems, and automation, as well as familiarity with Computer System Validation (CSV) within regulated environments.
Candidates must meet the following minimum requirements to be considered:
  • Bachelor’s Degree or higher in Engineering, Computer Science, Chemistry, or a related technical discipline.
  • Proven background supporting operations within a pharmaceutical manufacturing environment.
  • Demonstrated experience in Commissioning and Qualification (C&Q) activities.
  • Hands-on experience with Change Control processes, including documentation, impact assessment, and implementation within a GMP-regulated environment.
  • Strong working knowledge of cGMP regulations, ensuring compliance with regulatory standards and internal procedures.
  • Proficiency in technical documentation in English, including protocols, reports, and general project documentation; strong working knowledge of MS Office applications (Word, Excel, PowerPoint).
  • Fully bilingual (English and Spanish), with the ability to communicate effectively in both written and verbal formats.
  • Practical experience in Computer System Validation (CSV).
  • Experience utilizing ALM platforms for execution of qualification protocols and documentation lifecycle management.
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.

mîrus Consulting Group