Commissioning & Qualification Specialist

For Commissioning and Qualification services in the Capital Projects area.  

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Science or Engineering and a minimum of five (5) years of experience in the regulated industry.  
• Excellent written and verbal skills in both English and Spanish.
• Technical writing skills and problem-solving skills. 
• Experience in:
  • Drug Substance, Filling, Inspection, and Packaging.
  • Facilities and Utilities systems
  • Equipment Qualification (IQ/OQ/PQ), Validation Lifecycle Management, and Technical Writing.
  • Conceptual Design, Detailed Design, Planning, Execution, and Qualification.

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 Be The Piece?  

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Lead the drafting, review, and execution of validation protocols, ensuring accurate process documentation and deviation management.
• Apply advanced validation concepts and lifecycle processes to maintain the qualified state of all systems and equipment.
• Provide technical expertise during the conceptual and detailed design phases to ensure validation requirements are integrated from the start.
• Develop and implement validation engineering policies and procedures that impact multiple organizational units and improve site efficiency.
• Coordinate and review the work of a technical staff of engineers and technicians, providing guidance on both an ongoing and project-specific basis.
• Employ advanced validation techniques and ingenuity to develop technical solutions for complex engineering problems.
• Partner with Project Managers to ensure all validation activities are completed within schedule, budget, and quality constraints.
• Develop and manage departmental or project-specific budgets across multiple disciplines for small- to mid-sized projects.
• Lead the planning and scheduling of work activities alongside operations staff to minimize production impact.
• Work closely with Manufacturing, Process Development, Utilities, Labs, and Quality Assurance to develop requirements for highly complex facility modifications.
• Maintain an up-to-date cGMP training status and assist in evaluating maintenance procedures to optimize the overall validation program.

BEING A FITS PIECE COMES WITH PERKS:

WHO WE ARE:

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?