C&Q Program Lead

​ For Commissioning & Qualification Lead Services .

About fitspr

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.

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).

Talk with us to find out!

We are a Service Provider company different 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 industry clients with top-notch quality talent.

We're FITS!

Are you the Next Piece? ​

Responsibilities

• In-depth knowledge of regulatory requirements and industry standards for commissioning and qualification.
• Administrative, and according to business needs.
• Good skills in writing general documentation in English and using MS Office applications.
• Develop and implement C&Q strategies, execution plans, schedules, and procedures to ensure regulatory compliance and alignment with project objectives.
• C&Q deliverables, execution activities, and acceptance of Mechanical Completion (MC) documentation, ensuring compliance with quality standards and project timelines.
• 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.

Requirements

• 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.
• 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.
• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course).

However, that’s not all we have to offer.