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Validation Engineer

SoTalent

Washington · flexible Full-time Mid Level 5d ago

About the role

About

Our client is seeking a Validation Engineer to support compliance and quality within a regulated manufacturing setting. This position focuses on ensuring that systems, equipment, and processes meet stringent industry and regulatory requirements. It’s a hands-on role suited to someone with experience in validation within GMP-regulated environments.

Key Responsibilities

  • Develop and implement validation strategies, including protocols, risk assessments, and qualification plans
  • Serve as a subject matter expert on validation, advising cross-functional teams and supporting operational decision-making
  • Lead or contribute to validation activities tied to change controls, capital projects, and ongoing compliance initiatives
  • Collaborate with departments such as Engineering, Manufacturing, Quality, IT, and Supply Chain to manage priorities and improve efficiency
  • Execute validation tasks independently, occasionally taking ownership of projects within the validation function
  • Respond to equipment qualification requests and ensure timely delivery of validation support
  • Promote a culture focused on quality, compliance, and continuous improvement
  • Stay informed on relevant regulatory standards and ensure ongoing adherence
  • Participate in audits and inspections, representing validation processes when required
  • Oversee qualification of laboratory and production equipment, including analytical tools and monitoring systems
  • Apply risk-based approaches to improve validation timelines without compromising quality
  • Identify and implement opportunities to enhance validation processes and operational efficiency
  • Support training initiatives to strengthen team capability in validation practices

Skills and Experience

  • Degree in engineering, life sciences, or a related STEM discipline
  • At least 2 years of experience in commissioning, qualification, and validation within regulated industries
  • Strong understanding of GMP and associated frameworks (e.g., data integrity, computer system validation, and regulatory guidelines)
  • Practical experience with equipment, facility, and utility qualification processes
  • Familiarity with deviation management, investigations, and corrective/preventive actions is advantageous
  • Knowledge of validation lifecycle documentation, from initial requirements through to final qualification and system retirement
  • Strong organisational, communication, and technical writing skills
  • Experience using electronic systems for managing quality and validation documentation is beneficial
  • Ability to represent technical work confidently to internal stakeholders and external auditors
  • Background in pharmaceutical or biopharmaceutical environments preferred

Working Style

This role suits someone detail-oriented with a proactive mindset, capable of working both independently and collaboratively. A willingness to learn, support colleagues, and continuously improve processes is highly valued.

Rewards and Benefits

The position offers a competitive salary along with potential performance-based incentives. A comprehensive benefits package is provided, which may include healthcare coverage, financial protection plans, wellbeing programs, and retirement savings options.

Employees may also benefit from flexible time-off policies, paid holidays, and additional leave options depending on eligibility. Work-life balance is supported through various initiatives, including flexible scheduling and wellbeing resources.

Skills

Computer System ValidationData Integrity

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