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Lead Validation Engineer

2 months ago

Albuquerque, New Mexico, United States curiate Full time

Position Overview:

The Senior Validation Engineer plays a crucial role in the expansion of our operations, collaborating with Validation Contractors to ensure the highest standards of quality and compliance.

Key Responsibilities:

  • Develop and implement validation and revalidation protocols for various processes, equipment, utilities, and testing systems.
  • Create and document Standard Operating Procedures (SOPs) for new processes and equipment.
  • Assist engineering teams with ongoing projects by providing validation support.
  • Facilitate internal and external audits by presenting relevant data as needed.
  • Keep management informed about validation-related issues that may impact regulatory compliance or financial performance.
  • Ensure adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs) in all change controls and records.
  • Review and finalize validation protocols and reports for the release of tested equipment.
  • Participate in the evaluation of validation protocols for computer systems, environmental monitoring, process validations, and cleaning validations.
  • Provide validation oversight for facility upgrades and technology transfers.
  • Maintain current training and compliance with SOPs.

Qualifications:

  • Bachelor's degree in Science, Engineering, or a related field.
  • A minimum of eight years of relevant experience in pharmaceutical validation, particularly in aseptic or sterile environments.
  • Familiarity with FDA and EU regulations concerning pharmaceuticals and validation practices is preferred.
  • Experience with validation tools and methodologies is advantageous.

Skills and Abilities:

  • Strong technical writing skills for creating validation documentation.
  • Excellent communication skills, both verbal and written.
  • Ability to work independently while effectively collaborating with various technical departments.
  • Proficient in Microsoft Office Suite and other relevant software tools.
  • Strong attention to detail and organizational skills to manage multiple projects.

Work Environment:

The role may involve working in diverse environments, including office, manufacturing, and warehouse settings, with specific requirements for personal protective equipment in sterile environments.

This position requires a commitment to safety and adherence to established protocols to maintain a healthy work environment.

Curia is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status.