Validation Inventory & Remediation Analyst

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Inventory & Remediation Analyst

Description:

Support inventory analysis to define the scope of remediation across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM) by leveraging automated tools and site-level expertise. This role will ensure data accuracy, completeness, and alignment with current validation and remediation requirements.

Utilize automated tools to extract and filter validation documentation, review and validate extracted data, execute detailed assessments across OQ, PQ, TMV, and IPM, and ensure alignment with current procedures, global validation standards, and remediation expectations and timelines.

Responsabilities:

• Validate that extracted data accurately reflects site practices and documentation.
• Cross-check validation records against MVPs, PRAs, and supporting validation documentation.
• Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
• Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis.
• Confirm applicability of validation documentation.
• Identify discrepancies such as missing, conflicting, or outdated records.
• Proactively identify data gaps, inconsistencies, and tool limitations.
• Escalate risks, uncertainties, or blockers to the core team in a timely manner.
• Provide clear documentation of findings and recommended actions.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in Validation (OQ/PQ/TMV/IPM), Quality Engineering, or Manufacturing Engineering.
• Strong understanding of validation lifecycle and documentation in regulated environments (FDA, ISO, GMP).
• Experience with data analysis tools (Excel – advanced) and document management systems (e.g., Windchill preferred).
• Strong analytical and problem-solving skills.
• High attention to detail and data integrity.
• Ability to apply technical judgment in ambiguous scenarios.
• Effective communication and escalation skills.
• Ability to work independently in a fast-paced, high-priority environment.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Strong knowledge (according to related area).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.