Process Validation Specialists

CIS International LLC

  • Las Piedras, PR
  • Autónomo
  • Tiempo completo
  • Hace 1 mes
Job Summary:The Validation Specialists team will support process validation and cleaning validation activities for a technology transfer project in a pharmaceutical manufacturing environment. This role involves developing technical documentation for change control, process validation and cleaning validation as well as performing sampling and handling in compliance with regulatory standards.Key Responsibilities:
  • Develop, execute, and review process validation protocols (IQ, OQ, PQ) for technology transfer projects, also reports and master plans.
  • Define and monitor critical process parameters and critical quality attributes.
  • Support process performance qualification for new and existing products.
  • Prepare and maintain technical documentation for change control, validation reports, and regulatory submissions.
  • Conduct sampling activities in assigned areas, ensuring proper handling and documentation in a regulated environment.
  • Collaborate with manufacturing, quality assurance, regulatory, and engineering teams to ensure validation compliance.
  • Analyze validation data, identify trends, and recommend improvements to optimize manufacturing processes.
  • Ensure compliance with GMP, FDA, and industry regulations related to validation activities.
  • Support audits and inspections by providing validation documentation and technical expertise.
  • Assist in troubleshooting and resolving validation-related issues during technology transfer.
Qualifications & Experience:
  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • 3-5 years of experience in process validation within a pharmaceutical or regulated manufacturing environment.
  • Strong understanding of GMP, FDA, and ISO regulations related to validation and technology transfer.
  • Experience in change control documentation and validation lifecycle management.
  • Hands-on experience with sampling techniques and regulatory handling procedures.
  • Excellent analytical, problem-solving, and technical writing skills.
  • Ability to work independently and collaboratively in a cross-functional team.
Preferred Skills:
  • Knowledge of statistical analysis tools for validation data interpretation.
  • Ability to operate specialized laboratory equipment and computers as appropriate.
  • Ability to interpret and apply GLPs and GMPs.
  • Familiarity with risk assessment methodologies in validation processes.
Work Methodology:
  • Professional services contract
  • 6-12 months of project assignment with potential extension
  • Administrative shift Monday to Friday, 8am - 5pm with availability to support activities in non-standard hours
  • On-site job in Las Piedras - Puerto Rico
  • Languages: Spanish and English (verbal and written)

CIS International LLC