C&Q Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

6d • Onsite

About The Position

For C&Q services in the Business Operations area. This role involves supporting the planning and execution of commissioning, qualification, and validation (CQV) activities. The specialist will develop qualification protocols, support and effectively influence to ensure all necessary CQV activities are completed on time and according to the validation program, and develop validation status reports. Responsibilities also include participating in and supporting Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) of new equipment, recording results legibly and verifiably following data integrity principles (ALCOA) where applicable, reporting deviations during tests, proposing corrective actions, and participating in the implementation and verification of corrections. Additionally, the role requires planning and coordinating resources, measurement/calibration equipment, and tooling needed for tests, and complying with site safety rules, permits, and policies while on site.

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

• Treats everyone they meet like family, especially our resources, clients and team members.
• Customer service pro.
• Full of bright ideas and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level