C&Q Lead

Flexible & Integrated Technical Services, LLC; Vilafranca del Penedès; On-site; EUR 70,000 - 90,000; Full time

Job summary

FITS LLC in Spain seeks a CQV support professional for the Global Engineering area. The role requires 7+ years in commissioning, qualification, validation, and related disciplines within regulated industries.

Bilingual Spanish and English, with strong communication, organization, and problem-solving skills, is essential. You will lead day-to-day C&Q activities, coordinate engineers, contractors, and vendors, and support plans, schedules, and documentation to meet project milestones while

Qualifications

• Bachelor’s degree required in Life Science or Engineering.
• 7+ years of experience in commissioning, qualification, validation.
• Experience in pharmaceutical, biotech, medical device, or regulated industries.
• Strong communication and problem-solving skills.
• Bilingual Spanish & English.

Responsibilities

• Lead and coordinate day-to-day C&Q activities for assigned systems and project areas.
• Coordinate C&Q engineers, subject matter experts, contractors, and equipment vendors.
• Support the C&Q Manager in developing and maintaining C&Q plans, schedules, resource requirements, and deliverables.
• Ensure C&Q activities are incorporated into the integrated project schedule and delivered on milestones.
• Apply risk-based commissioning and qualification principles to assigned systems.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support deviations, non-conformances, test failures, punch-list items, and other C&Q issues.
• Coordinate with engineering, construction, quality, operations, maintenance, automation, project controls, and external vendors.
• Provide regular updates on C&Q progress, risks, issues, and schedule performance.
• Support factory acceptance testing, site acceptance testing, system turnover, and readiness activities.
• Ensure all activities comply with health, safety, environmental, quality, and GMP requirements.

Skills

Bilingual Spanish & English

C&Q coordination

Contractor/vendor coordination

Regulated industry experience

Multi-priority management

Risk-based commissioning

Education

Bachelor’s Degree in Life Science or Engineering

Job description

For CQV support in the Global Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Life Science or Engineering, andseven years (7+)of experience in commissioning, qualification, validation, engineering, or related discipline within the pharmaceutical, biotechnology, medical device, or other regulated industry.
• Bilingual (Spanish & English)
• Strong communication, organizational, and problem-solving skills.
• Ability to manage multiple priorities and work effectively in a fast-paced project environment.
• Experience in:
• Coordinating or leading C&Q activities on pharmaceutical capital projects.
• Facilities, clean utilities, process utilities, HVAC, water systems, process equipment, manufacturing systems, or laboratory systems.
• developing, reviewing, and executing C&Q documentation and protocols.
• supporting deviations, change controls, non-conformances, and corrective actions.
• engineering contractors, equipment vendors, construction teams, and site operations.

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• Lead and coordinate day-to-day C&Q activities for assigned systems and project areas.
• Coordinate C&Q engineers, subject matter experts, contractors, and equipment vendors.
• Support the C&Q Manager in developing and maintaining C&Q plans, schedules, resource requirements, and deliverables.
• Ensure C&Q activities are incorporated into the integrated project schedule and delivered in line with project milestones.
• Apply risk-based commissioning and qualification principles to assigned systems.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support the investigation and resolution of deviations, non-conformances, test failures, punch-list items, and other C&Q issues.
• Coordinate with engineering, construction, quality, operations, maintenance, automation, project controls, and external vendors.
• Provide regular updates on C&Q progress, risks, issues, and schedule performance.
• Support factory acceptance testing, site acceptance testing, system turnover, operational readiness, and project handover activities.
• Support audits, inspections, and project readiness reviews as required.
• Ensure all activities are performed in accordance with applicable health, safety, environmental, quality, and GMP requirements.

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?