Commissioning & Qualification Specialist

Flexible & Integrated Technical Services • Guayama, PR

9d

About The Position

For C&Q services in the Manufacturing and Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Life Sciences or Engineering and previous exposure to Validation and/or Qualification activities within the pharmaceutical and medical devices industry. Bilingual: (Spanish and English) Shift: Administrative & according to business needs 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 take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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?

Requirements

• Bachelor’s Degree in Life Sciences or Engineering and previous exposure to Validation and/or Qualification activities within the pharmaceutical and medical devices industry.
• Bilingual: (Spanish and English)
• Experience in: Validation principles, protocols (IQ, OQ, PQ, CSV ), and lifecycle management
• Manufacturing equipment. (Fette, CTC)
• GMP & GDP regulations

Responsibilities

• Execute and manage the qualification lifecycle for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop, review, and execute validation protocols and reports in accordance with GMP and company standards.
• Generate and maintain change control documentation for equipment and process modifications.
• Perform troubleshooting and root cause analysis for validation-related issues.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout all validation activities.
• Collaborate with manufacturing, packaging, and quality teams to support equipment qualification and process improvements.
• Maintain accurate and timely documentation in alignment with internal SOPs and regulatory expectations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level