Digital Validation Solution Expert

Job Title: Digital Validation Solution Expert
Job Location: 1 DNA Way, South San Francisco, CA 94080
Duration: 12 months contract with possibility for extension or conversion into FTE
Pay Rate: $54.49 - $71.80 per hour on W2

Job Description
The Digital Validation Solution Expert (ValGenesis) (Validation Master Data Manager and User Support) is a vital member of the Global MSAT & Engineering team (PTT). This role is responsible for maintaining and updating the master data in a centralized paperless validation system and providing critical user support across the network. It involves managing templates, ensuring standardization, handling data migration tasks, processing change requests, and ensuring accurate record-keeping.

This position requires a strong understanding of Qualification and Validation business processes, an innovative and problem-solving mindset, and the ability to collaborate effectively with Global and Local MSAT, Engineering, Quality, and IT organizations.

Key Responsibilities

• Maintain accurate and organized system validation documentation standards, ensuring compliance with regulatory requirements and company policies.
• Collaborate with cross-functional teams, including Quality, Manufacturing, and Engineering, to ensure successful validation systems and qualification activities.
• Investigate and resolve challenging validation issues by applying scientific and engineering principles, implementing corrective actions as needed.
• Collaborate with suppliers to troubleshoot existing issues, test/deploy new features, and support new module master data builds.
• Work closely with validation and qualification SPOCs, SMEs, and Site Business Process Managers to translate aligned business processes into master data and support system adoption.
• Implement changes to master data, including specifications, within the ValGenesis software.
• Manage template uploads, binding to content types at all sites, and oversee template revisions.

Qualifications

• Familiarity with the ValGenesis Validation Lifecycle Management System is required.
• 3–5 years of work experience in the pharmaceutical or biotechnology industry with process development, operations/manufacturing, or related experience.
• Proficiency in validation methodologies, risk assessments, and related documentation.
• Experience resolving issues with a variety of project documentation, including business and functional requirements, validation test protocols, and technical support documentation.
• Excellent interpersonal and collaboration skills with a proven track record of building sustainable relationships with internal and external stakeholders.
• Ability to coach colleagues with less experience, provide guidance, motivation, and influence.
• Demonstrated ability to role model effective risk-taking and decision-making while developing others’ skills and expertise.
• Proven capability to identify medium/high-risk opportunities, implement solutions, and solve problems proactively.
• Strong communication and presentation skills with the ability to frame communications to fit diverse audiences, demonstrating executive presence and confidence.
• Ability to synthesize and summarize complex issues to expedite agreements and decision-making.
• Strong attention to detail with a commitment to data accuracy and integrity.
• Demonstrates accountability, manages multiple priorities, and stays on track with objectives independently within complex environments.
• Self-starter who manages commitments and deliverables proactively, exercising wide latitude in work approach.

Travel Requirements

• No travel required.
• Relocation benefits are not available.

Other Requirements

• Ideal candidate should be located within the Eastern Time Zone to support global projects.

Working Model: Remote
Must Have: ValGenesis experience

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