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Systems Validation Specialist
2 months ago
Job Title – Systems Validation Specialist
Location - Remote
Duration – 12+ Months Contract
Work hours: 9am-5pm
Client: MillenniumSoft
Job Category: Scientific
Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
No H1B's
Overview:
MillenniumSoft is in search of a dedicated and skilled Systems Validation Specialist to join our dynamic product development team. This role is essential in ensuring that our innovative cell analysis solutions perform exceptionally and meet our clients' high standards.
Key Responsibilities:
• Spearhead the design, definition, and execution of system validation activities for instrument projects.
• Formulate strategies for testing product specifications, including testing methodologies, sample sizes, and resource requirements.
• Create and document system validation and verification test protocols to assess product specifications.
• Serve as a bridge between the Program Core Team and the Systems Validation and Reliability team.
• Advocate for customer needs and product excellence on collaborative projects.
• Utilize independent judgment and apply critical thinking, problem-solving, and troubleshooting skills.
• Conduct representative sample preparation and flow cytometry experiments to evaluate products.
• Stay informed about customer workflows, advancements in flow cytometry, and industry trends.
• Mentor junior team members in best practices for systems validation.
• Provide clear and structured updates on critical issues.
Minimum Qualifications:
• Bachelor’s degree in Immunology, Cell Biology, Engineering, or a related field.
• At least 5 years of experience in systems validation and verification principles within the biotech, pharmaceutical, or clinical research sectors.
• Strong understanding of flow cytometry applications and hands-on experience with flow cytometry analyzers and sorters.
• Proficient in sample preparation and experimental design for multi-parameter flow cytometry applications.
• Ability to achieve technical goals and address challenges in fast-paced environments.
• Experience in training laboratory personnel and leading projects.
• Excellent communication skills, both written and verbal.
• Capable of working with human blood or blood products, demonstrating strong laboratory skills and meticulous sample handling.
Preferred Qualifications:
• Master’s or Ph.D. in Immunology, Cell Biology, Engineering, or a related discipline.
• Experience in product development and design control processes.
• Familiarity with regulatory medical device industry standards and regulatory submissions.
• Knowledge of systems engineering practices.
At MillenniumSoft, we are committed to enhancing the health and well-being of individuals by providing cutting-edge tools for research and clinical laboratories. Join us in our mission to advance scientific discovery and improve clinical outcomes.
