C&Q Program Lead

Flexible & Integrated Technical Services, 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

For Commissioning &Qualification Lead Services .

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Life Science or Engineering.
• Minimum of 10 years of experience in commissioning and qualification
  (C&Q) 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:
• 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 focuson identifying and implementing improvements in C&Q practices.

The Personality Part:

• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• 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.

BEING A FITS PIECE COMES WITH PERKS:

• One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!

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?