Senior Validation Engineer

6 days ago

Minneapolis, Minnesota, United States Intellectt Inc Full time
Job Title: Senior Validation Engineer

We are seeking a highly experienced Senior Validation Engineer to lead validation activities for equipment, processes, systems, and facilities in a regulated environment.

Key Responsibilities:
  • Validation Planning and Execution: Develop, review, and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, utilities, and processes.
  • Process Validation: Perform and oversee process validation activities, including cleanroom qualifications, sterilization validation, cleaning validation, and packaging validation.
  • Equipment and System Validation: Validate manufacturing equipment, automation systems, laboratory equipment, and software systems (e.g., SCADA, PLC).
  • Compliance and Documentation: Prepare detailed validation reports, summary reports, and maintain validation documentation in accordance with FDA, EU, and ISO standards.
  • Risk Assessments: Conduct and document risk assessments, Failure Modes and Effects Analysis (FMEA), and root cause analysis.
  • Change Control: Support change control activities by evaluating the impact of changes on validated systems and ensuring re-validation as necessary.
  • Cross-Functional Collaboration: Work with Manufacturing, Quality Assurance, Engineering, and other departments to ensure timely execution of validation activities.
  • Audit and Regulatory Support: Participate in internal and external audits, including FDA inspections, ISO audits, and customer audits. Provide expertise during regulatory filings.
  • Continuous Improvement: Identify opportunities for process optimization and validation best practices. Stay current with regulatory changes and emerging validation techniques.
Requirements:
  • Education: Bachelor's degree in Engineering (Mechanical, Electrical, or Chemical), Biotechnology, or a related technical field. A Master's degree is preferred.
  • Experience: 8+ years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.
  • Regulatory Knowledge: Strong understanding of FDA regulations (21 CFR Part 11, 210, 211), EU GMP, ISO 13485, ICH Q8/Q9/Q10, and other relevant standards.
  • Technical Skills:
  • Expertise in validation of equipment, processes, facilities, utilities, and computer systems.
  • Hands-on experience with Process Analytical Technology (PAT) and statistical techniques for process control.
  • Proficiency with validation lifecycle management (VLM) software, project management tools, and MS Office Suite.
  • Experience with thermal mapping, sterilization methods (steam, EtO, gamma), cleaning validation, and environmental monitoring systems.
  • Project Management: Proven ability to lead and manage validation projects, prioritize tasks, and meet deadlines.
  • Analytical Skills: Strong problem-solving, data analysis, and root cause analysis skills. Ability to interpret complex data and make informed decisions.
  • Communication: Excellent written and verbal communication skills. Ability to prepare detailed validation protocols, technical reports, and present findings to diverse stakeholders.
  • Teamwork and Leadership: Proven leadership skills with experience guiding teams through validation processes. Ability to mentor junior engineers and work effectively in cross-functional teams.

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