Senior C&Q Program Lead - Pharma Projects

FITS LLC; Carolina (PR); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Excellent customer service

Job summary

FITS LLC is seeking a Commissioning & Qualification Lead to head the C&Q program across multiple nodes in our Island-wide operations. You will craft strategies, schedules, and procedures to meet regulatory standards and project goals, while aligning with cross-functional teams and vendors.

You will oversee MC documentation, FATs, pre-commissioning activities, and handovers to User teams, ensuring safety and continuous improvement across the site.

Qualifications

• Bachelor’s Degree in Life Science or Engineering.
• Minimum of 10 years of experience in commissioning and qualification activities, preferably within the pharmaceutical or biotechnology industry.
• In-depth knowledge of regulatory requirements and industry standards for commissioning and qualification.
• Bilingual (Spanish & English).
• Shift: Administrative, and according to business needs.
• Good skills in writing general documentation in English and using MS Office applications.
• Experience in API manufacturing facility CQV.
• Experience leading or coordinating C&Q activities across multiple facilities, systems, or workstreams within a large-scale capital project.
• Strong leadership and team management skills, with the ability to coordinate and oversee multiple C&Q activities simultaneously.
• Excellent analytical and problem-solving abilities, with a focus on identifying and implementing improvements in C&Q practices.

Responsibilities

• Serve as the primary point of contact and technical leader for the Commissioning & Qualification (C&Q) Program across all assigned Nodes.
• Develop and implement C&Q strategies, execution plans, schedules, and procedures to ensure regulatory compliance and alignment with project objectives.
• Oversee C&Q deliverables, execution activities, and acceptance of Mechanical Completion (MC) documentation, ensuring compliance with quality standards and project timelines.
• Coordinate Factory Acceptance Tests (FATs), pre-commissioning activities, utility demands, temporary power, wastewater discharge, and related infrastructure requirements.
• Manage punch list closure in collaboration with C&Q firms and SWAT teams, support Lockout/Tagout (LOTO) coordination, and facilitate system handovers to User teams.
• Collaborate with C&Q Node Leads, vendors, Construction Managers (CMs), and cross-functional teams to align resources, execution plans, and deliverables.
• Monitor and report program metrics, including progress, change management, critical path analysis, resource allocation, risks, and 2-4-week look-ahead schedules.
• Identify and mitigate risks, drive continuous improvement, and enforce site safety standards and industry best practices throughout all C&Q activities.

Skills

C&Q experience

Regulatory knowledge

Bilingual (Spanish/English)

Leadership

Documentation & MS Office

Cross-facility coordination

Analytical/problem solving

Education

Bachelor’s Degree in Life Science or Engineering

Tools

MS Office

Job description

FITS LLC is seeking a Commissioning & Qualification Lead to head the C&Q program across multiple nodes in our Island-wide operations. You will craft strategies, schedules, and procedures to meet regulatory standards and project goals, while aligning with cross-functional teams and vendors.

You will oversee MC documentation, FATs, pre-commissioning activities, and handovers to User teams, ensuring safety and continuous improvement across the site.