C&Q Executer

Flexible & Integrated Technical Services, LLCJuncos, PR
Onsite

About The Position

This role is for C&Q services in the Business Operations area. The ideal candidate will have a Bachelor’s Degree in Science or Engineering with at least 2 years of proven experience in commissioning and qualification processes, protocol generation and execution. The position requires bilingualism in Spanish and English and operates on an administrative shift according to business needs. The role involves executing commissioning and qualification activities in the field, generating protocols and technical documents in line with industry standards and regulatory requirements (e.g., cGMP, FDA, ISPE/ASTM E2500), reporting deviations, proposing corrective actions, and participating in their implementation. It also includes planning and coordinating resources, equipment, and tooling for tests. The ideal candidate is customer-service oriented, innovative, and committed to delivering top-quality results.

Requirements

  • Bachelor’s Degree in Science, or Engineering field
  • At least 2 years of proven experience in commissioning and qualification processes, protocol generation and execution.
  • Bilingual (Spanish and English).
  • Executing commissioning and qualification activities in the field.
  • Generating protocols and technical documents in line with current industry standards and regulatory requirements (e.g., cGMP, FDA, ISPE/ASTM E2500).
  • Reporting deviations during tests, proposing corrective actions, and participating in the implementation and verification of corrections.
  • Planning and coordinating resources, measurement/calibration equipment, and tooling needed for tests.

Nice To Haves

  • Customer service pro
  • Innovative
  • Eager to innovate
  • Always bringing top-quality results to the table

Responsibilities

  • Support the planning and execution of commissioning, qualification, and validation (CQV) activities.
  • Develop qualification protocols.
  • Support and influence effectively to ensure all necessary Commissioning, Qualification, and Validation (CQV) activities are completed on time and according to the validation program.
  • Developing validation status reports.
  • Participate in and support Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) of new equipment.
  • Record results legibly and verifiably, following data integrity principles (ALCOA) where applicable.
  • Report deviations during tests, propose corrective actions, and participate in the implementation and verification of corrections.
  • Plan and coordinate resources, measurement/calibration equipment, and tooling needed for tests.
  • Comply with site safety rules, permits, and policies while on site.
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