C&Q Executer

FITS LLC; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a CQV specialist to support commissioning, qualification, and validation activities across pharma, medical device, and manufacturing sectors. The role requires a science/engineering degree and hands-on CQV field experience.

You will generate protocols, document deviations, coordinate resources, and ensure data integrity while complying with cGMP, FDA, and ISPE/ASTM E2500 standards. Bilingual Spanish-English is a plus.

Qualifications

• Bachelor’s Degree in Science or Engineering with at least 2 years of proven CQV experience.
• Bilingual Spanish and English.
• Experience in commissioning and qualification activities in the field.
• Generate protocols and technical documents aligned with cGMP, FDA, ISPE/ASTM E2500.
• Report deviations, propose corrective actions, and verify corrections.
• Plan and coordinate resources and equipment for tests.

Responsibilities

• Support the planning and execution of commissioning, qualification, and validation activities.
• Develop qualification protocols.
• Ensure CQV activities are completed on time and per the validation program.
• Develop validation status reports.
• Participate in FAT and SAT of new equipment.
• Record results with data integrity (ALCOA).
• Report deviations and assist in corrective actions.
• Plan and coordinate resources and tooling for tests.
• Comply with site safety rules and policies.

Skills

Bilingual Spanish-English

CQV field experience

Protocol generation

Resource planning

Education

Bachelor's Degree in Science or Engineering

Tools

Measurement/Calibration equipment

Testing equipment

Job description

For C&Q services in the Business Operations area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Science, or Engineering field with at least 2 years of proven experiencein commissioning and qualification processes, protocol generationand execution.
• Bilingual (Spanish and English.)
• Shift: Administrative and according to business needs.
• Experience in:
• 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.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you\'re full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• Support the planning and executionof 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 AcceptanceTest(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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company\'s puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources\' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We\'re FITS!

Are you the Next Piece?