Validation Lead & Business Analyst

• Hi,
• We are currently looking for qualified candidates for the below requirement. Please share any available candidates who meet the requirements

• Validation Lead & Business Analyst
• Remote
• Contract: 12+ Months

• Key Responsibilities
• - Knowledge of pharmaceutical and/or Cell & Gene Therapy (CGT) supply chain processes is a plus.
• - Experience with AP ALM, Jira, and Agile methodologies for project delivery.
• - Strong written and verbal communication skills; fluency in English is required.
• - Travel Requirement: Up to 20%, as needed.

Required Skills and Qualifications

• 1. Domain Expertise
• - Demonstrated experience working in pharmaceutical laboratories, specifically in:
• - Analytical Development (AD)
• - Quality Control (QC)
• - Manufacturing Science & Technology (MSAT)
• - Experience in Cell and Gene Therapy (CGT) testing, such as cell viability, flow cytometry, ddPCR, and potency assays, is

• preferred.
• 2. Lab Informatics & Integration Platforms
• - Experience with the Tetra Data Platform (TDP) is a plus.

3. Enterprise Laboratory Systems Knowledge

• - Familiarity with Level 3 laboratory ecosystems, including:
• - Laboratory Information Management Systems (LIMS), such as LabWare and Benchling
• - Electronic Lab Notebooks (ELN)
• - Chromatography Data Systems (CDS), such as Empower
• - Scientific Data Management Systems (SDMS)

4. Data Modeling Understanding

- Foundational knowledge of structured data formats:

• - JSON
• - XML
• - CSV
• - Parquet
• - Understanding of data contextualization and schema mapping.

5. Regulatory & GxP Compliance

- Strong working knowledge of:

• - Computer System Validation (CSV) / Computer Software Assurance (CSA)
• - GAMP 5
• - 21 CFR Part 11
• - Data integrity principles for Quality Control (QC) release environments.

Education : At least a bachelor’s degree (or equivalent experience) in Computer Science, Software Engineering, Electronics Engineering, Information Systems, or a closely related field is required for the project