CQV Specialist

Cedrela Talent; San Juan (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

San Juan, United States – Cedrela Talent seeks a CQV consultant to deliver technical support for Commissioning, Qualification, and Validation. The role focuses on ensuring schedules stay on track, updating document status, and supporting project meetings.

The consultant will monitor risks and coordinate validation efforts across CQV activities. Key tasks include CQV protocols development, report generation, change controls management, and DOE planning.

Qualifications

• Bachelor’s degree in Engineering or a Scientific field is required.
• 5+ years of experience in a regulated industry preferred.
• Strong written and oral communication skills; ability to collaborate effectively.

Responsibilities

• Review CQV documents following standards and procedures.
• CQV Protocols development, execution coordination, execution, interpretation, approval, and report generation.
• Relocation activities.
• Develop CQV assessments.
• User Requirement development and approval.
• Functional Requirement & Design Specifications development and approval.
• Develop CQV Plan.
• Generate, review, get approval, and manage new SOPs and/or modify existing ones as required.
• Owns, generates, reviews, gets approval, and manages Change Controls as required.
• Performs validation assessments as part of the change control process and verify with the Change Owner and/or System Owner that there is no change control records in progress that could impact on the same validated system before the start of each validation exercise.
• Other CQV tasks may be assigned as needed.
• A statistical consultant is requested for the design of experiments (DOE).

Education

Bachelor’s degree in Engineering or a Scientific field

Job description

San Juan, United States |

The consultant will deliver technical support for Commissioning, Qualification, and Validation (CQV). The CQV consultant is accountable for all CQV-related activities. This includes providing an update on the status of each document. The validation service will serve as the primary means to ensure that the schedule remains on track. The validation consultant should notify the project manager of any risks that could impact on the project plan and should provide support during project meetings.

Responsibilities

• Review CQV documents following standards and procedures
  
• CQV Protocols development, execution coordination, execution, interpretation, approval, and report generation
  
• Relocation activities
  
• Develop CQV assessments
  
• User Requirement development and approval
  
• Functional Requirement & Design Specifications development and approval
  
• Develop CQV Plan
  
• Generate, review, get approval, and manage new SOPs and/or modify existing ones as required
  
• Owns, generates, reviews, gets approval, and manages Change Controls as required
  
• Performs validation assessments as part of the change control process and verify with the Change Owner and/or System Owner that there is no change control records in progress that could impact on the same validated system before the start of each validation exercise
  
• Other CQV tasks may be assigned as needed.
  
• A statistical consultant is requested for the design of experiments (DOE). This field of applied statistics focuses on the planning, execution, analysis, and interpretation of controlled tests. The aim is to evaluate the factors that influence the value of a parameter or group of parameters.
  

Requirements

Education

Bachelor’s degree in Engineering or a Scientific field.

Preferred Qualifications

• 5+ years of experience in a regulated industry.
  
• Strong knowledge of cGMP/FDA regulations.
  
• Ability to develop and adhere to self-directed standard work-organized and methodical with minimal guidance and be comfortable working as an individual and part of a team.
  
• Exercises Good Judgment and Drives Change for Competitive Advantage.
  
• Strong written and oral communication skills and ability to collaborate effectively with others.
  
• Strong interpersonal, leadership and influencing Skills, communication and motivation.
  
• Drives for Superior Results and Passion to Win with demonstrated record in getting things done.