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Sr. Validation Scientist 2879239

Job Title: Sr. Validation Scientist

Location: Juncos, PR (100% onsite work on Administrative shift)

Positions Available: 1

Duration: Approximately 7 months

This position is offered through ProQuality Network as a contract role.


Job Summary

The Sr. Validation Scientist will independently provide and/or direct technical validation engineering support for process and equipment upgrades, replacements, and modifications in laboratory, manufacturing, or manufacturing support environments.


Educational/Experience Requirements

  • Doctorate degree or
  • Master's degree with 3 years of directly related experience or
  • Bachelor's degree with 5 years of directly related experience or
  • Associate's degree with 10 years of directly related experience or
  • High School diploma/GED with 12 years of directly related experience


Preferred Qualifications

  • Experience with URS, DS, and Equipment Risk Assessments
  • Characterization and Validation expertise, including:
  • Development and execution of protocols
  • Creation of characterization and validation reports
  • Device assembly equipment and packaging equipment validation experience


Key Responsibilities

  • Troubleshoot systemic validation issues.
  • Apply advanced validation engineering principles for system or process modifications and/or capital projects.
  • Develop, organize, analyze, and present results for operational or engineering projects.
  • Complete complex or novel assignments requiring innovative validation techniques.
  • Develop policies and procedures impacting multiple organizational units.
  • Supervise and coordinate work of engineers or technicians.
  • Employ advanced validation techniques within area of expertise.
  • Develop technical solutions to complex problems using ingenuity and creativity.
  • Collaborate with manufacturing, process development, utilities, facilities, labs, and quality assurance teams to meet project requirements.
  • Manage validation responsibilities within schedule, budget, and quality constraints.
  • Contribute to departmental or project budgets.
  • Ensure prompt and regular attendance to the workplace. Other functions may be assigned as needed.


Knowledge and Skills

  • Advanced understanding of validation processes (e.g., equipment qualification, cleaning, sterilization).
  • Extensive technical expertise and knowledge of related disciplines.
  • Ability to solve complex technical problems using scientific and engineering principles.
  • Knowledge of regulatory trends and FDA (or equivalent) guidelines.
  • Effective interaction with diverse communication and working styles.
  • Capability to handle multiple projects simultaneously.


Competencies

  • Schedule development and facilitation
  • Collaboration and teamwork
  • Project management and completion
  • Leadership and team-building
  • Financial analysis and resource delegation
  • Negotiation and conflict resolution


Impact and Leadership

  • Drive successful completion of major programs and initiatives.
  • Represent the organization as the prime technical contact.
  • Act as a liaison with senior external personnel on significant technical matters.
  • Lead efforts and provide guidance to peers or direct reports.


Why Join Us?

At ProQuality Network, we connect professionals with opportunities that have a meaningful impact. This role offers the chance to contribute to high-impact projects while working in a dynamic and collaborative environment.

If you are a highly skilled Validation Scientist, we encourage you to apply inside the job description with your updated resume or share this opportunity with your network. Together, let’s advance innovative solutions and make a difference.


Apply today to join our network of professionals dedicated to excellence!



Thank you. We will be in contact soon.

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