CSV Specialist – Syncade MES

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎁 Product Marketing

👻 Ghost score 15%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CINCO Engineering

WebsiteLinkedInAll Job Openings

1 - 10 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

💰 $75k Seed Round on 2020-03

Consulting • Manufacturing • Biotechnology

CINCO Engineering is a Quality Risk Management solution provider focused on the Life Sciences sector. The company helps protect patients by managing risks associated with manufacturing processes in pharmaceuticals and biotechnology. They specialize in software development, validation, and regulatory documentation, ensuring compliance and safety in the manufacturing of life-saving products.

📋 Description

• Support validation activities for the Syncade MES, including new implementations, system enhancements, upgrades, and changes • Develop, review, and execute validation documentation in accordance with applicable procedures and regulatory requirements • Prepare and/or execute IQ, OQ, PQ, UAT, and regression testing activities as applicable • Develop and execute test scripts and document test results, deviations, and exceptions • Support requirements gathering and development of User Requirements Specifications (URS), Functional Specifications, and other validation deliverables • Ensure traceability between user requirements, functional requirements, risk assessments, and test cases • Support risk assessments and validation strategy development for Syncade-related systems and processes • Investigate and document validation discrepancies, deviations, and testing issues • Support change control activities associated with Syncade system modifications and enhancements • Collaborate with Manufacturing, Automation, IT, Quality, Engineering, and other cross-functional teams • Ensure validation documentation is complete, accurate, and compliant with applicable GxP, GMP, and data integrity requirements • Participate in validation planning, status meetings, execution activities, and project reviews • Support audits and inspections by providing validation documentation and technical information as required

🎯 Requirements

• Minimum of 3 years of experience in computer system validation, MES validation, or validation of computerized systems within a regulated environment • Hands-on experience with MES validation or implementation • Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, or manufacturing environment • Knowledge of computer system validation principles and applicable regulatory expectations • Experience developing and executing validation test scripts and documenting results • Familiarity with risk-based validation methodologies and change control processes • Strong technical writing and documentation skills • Ability to work effectively with cross-functional teams and communicate with technical and business stakeholders • Experience with Syncade system configuration, integration, or troubleshooting • Knowledge of MES functionality related to manufacturing, electronic batch records, materials, equipment, or production processes • Experience with 21 CFR Part 11, data integrity principles, and applicable GxP requirements • Familiarity with GAMP 5 and risk-based computerized system validation approaches • Experience supporting system upgrades, remediation, or continuous improvement initiatives