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Principal Validation Engineer

2 months ago

Spokane, Washington, United States Selkirk Pharma Full time
About the Role

We are seeking a highly skilled Principal Validation Engineer to join our team at Selkirk Pharma. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our equipment, manufacturing processes, and cleaning activities meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Develop and implement validation strategies for equipment, processes, and cleaning activities
  • Lead and manage validation projects, including qualification and validation protocols and procedures
  • Collaborate with cross-functional teams to develop and implement risk-based validation approaches
  • Provide technical expertise and guidance on validation and quality assurance matters
  • Develop and maintain technical documentation, including SOPs, specifications, and validation protocols
  • Ensure compliance with regulatory requirements, including 21 CFR Part 210 and Part 211, and GAMP 5
Requirements
  • Bachelor's degree in a relevant discipline, such as biology, chemistry, or engineering
  • At least 5 years of experience in a GMP or regulated environment
  • 8 years of combined experience in validation, quality engineering, or MSAT within the pharmaceutical or biotech industry
  • Experience with project management, including leading groups and project teams
  • Advanced technical understanding of validation and qualification requirements and concepts
What We Offer

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are a motivated and experienced validation professional looking for a new challenge, please submit your application.