57 applicants

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Company

Original Job Post

USDM Life Sciences · 2 days ago

Validation Lead

United States

Contract

Remote

Senior Level

$60/hr - $80/hr

5+ years exp

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BiotechnologyInformation Technology

Work & Life Balance

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Responsibilities

Lead validation activities for Polarian PLM & Plasmid Projects, including integrations and other related projects.

Develop and maintain validation plans, protocols, and reports following industry standards and regulatory requirements.

Ensure the team adheres to the Inspire Quality Initiative, maintaining high standards of quality and compliance.

Conduct thorough script reviews and validation plan assessments to ensure accuracy and completeness.

Identify and address testing issues, providing corrective actions and improvement recommendations.

Work closely with project managers, engineers, and other stakeholders to align validation activities with project goals.

Communicate validation status, issues, and risks to senior management and project stakeholders.

Ensure all validation documentation is complete, accurate, and compliant with regulatory standards.

Implement and maintain standard operating procedures (SOPs) for validation activities.

Coordinate with cross-functional teams to ensure timely and accurate completion of validation tasks.

Guide and mentor the validation team, promoting best practices and continuous improvement.

Maintain project integrity by ensuring all validation activities are conducted honestly and transparently.

Foster a collaborative environment that encourages knowledge sharing and teamwork.

Stay updated on industry trends, regulatory changes, and best practices in validation processes.

Qualification

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Validation principlesRegulatory requirementsIndustry standardsPolarian PLMPlasmid ProjectsSystem integrationsInspire Quality InitiativeQuality improvement programsValidation softwareScriptingAutomationLeadershipCommunicationInterpersonalDetail-orientedAnalyticalProblem-solving manage multiple projectsQuality AssuranceASQ CQACQM

Required

Minimum of 5 years of experience in validation, quality assurance, or related roles within the pharmaceutical, biotechnology, or medical device industry.

Strong knowledge of validation principles, regulatory requirements (FDA, EMA, etc.), and industry standards (GMP, GAMP, etc.).

Proven experience with Polarian PLM, Plasmid Projects, and system integrations.

Excellent leadership, communication, and interpersonal skills.

Detail-oriented with strong analytical and problem-solving abilities.

Ability to manage multiple projects and priorities in a fast-paced environment.

Experience with the Inspire Quality Initiative or similar quality improvement programs.

Proficiency in validation software and tools.

Knowledge of scripting and automation in validation processes.

Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.