Commissioning & Qualification (C&Q) Specialist - PR (South Region)

3 days ago

Guayama PR, United States -84b5-40fe-8f8c-7c5fee4324d5 Full time $60,000 - $85,000 per year

Overview

The Commissioning & Qualification (C&Q) Specialist supports the qualification lifecycle of manufacturing and packaging equipment within a GMP – regulated environment. This role ensures systems, utilities, and equipment meet established quality and regulatory requirements through the execution of protocols, troubleshooting activities, and effective change control management.

Responsibilities

  • Perform end-to-end qualification lifecycle activities, including commissioning, IQ, OQ, and PQ for manufacturing and packaging equipment.
  • Prepare, review, and execute qualification protocols and final reports in accordance with GMP and internal quality standards.
  • Generate and manage change controls associated with equipment, processes, and qualification activities.
  • Conduct troubleshooting to identify and resolve equipment or process deviations during qualification or commissioning phases.
  • Ensure all work complies with GMP, regulatory requirements, and company procedures.
  • Collaborate with cross-functional teams such as Engineering, Quality, Operations, and Technical Services to support project deliverables.

Qualifications

  • Bachelor's degree in Engineering, Science, or a related technical field.
  • 2–5 years of experience in Commissioning, Qualification, Validation, or Engineering roles within GMP-regulated environments.
  • Hands-on experience with manufacturing and packaging equipment qualification.
  • Strong understanding of the qualification lifecycle (Commissioning, IQ/OQ/PQ).
  • Ability to troubleshoot equipment performance or documentation issues.

Skills

  • Strong knowledge of GMP, FDA, and regulatory compliance requirements.
  • Proficiency developing and executing IQ/OQ/PQ protocols.
  • Technical understanding of manufacturing and packaging equipment operation.
  • Analytical and problem-solving abilities for equipment and process troubleshooting.
  • Excellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and compellingly.
  • Effective communication and teamwork skills for cross-functional collaboration.
  • Time management and ability to prioritize multiple activities in fast-paced environments.
  • Knowledge of change control systems and deviation management processes.
  • Fluent in both English and Spanish.

Join us as a C&Q Specialist, where your technical expertise will support robust qualification activities, ensure compliance with regulatory standards, and enhance cross-functional alignment through precise and effective communication.

Job Type: Contract

Education:

  • Bachelor's (Required)

Experience:

  • Commissioning, Qualification, Validation, or Engineering : 4 years (Required)

Work Location: In person

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