MES Validation Engineer

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🔥 0 minutes ago

🌲 Oregon – Remote

🌲 Oregon – Remote

💵 $75 - $84 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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DAWAR CONSULTING INC

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

⚕️ Healthcare Insurance

👥 HR Tech

☁️ SaaS

Healthcare Insurance • HR Tech • SaaS

DAWAR CONSULTING INC. is a trusted provider of workforce solutions and professional services tailored for the Medical Science industry. Specializing in Human Capital Management (HCM) and ITSM consulting, DAWAR offers expert implementation of SaaS and Cloud-based solutions from platforms like Workday and ServiceNow. Their comprehensive staffing services include global talent acquisition, recruitment process outsourcing, and staff augmentation, ensuring that they connect skilled professionals with career opportunities while enhancing organizational productivity and efficiency.

📋 Description

• Develop, author, review, and execute validation protocols, test scripts, and validation reports for MES and computerized systems. • Support implementation and validation of Rockwell FactoryTalk PharmaSuite and related manufacturing systems. • Collaborate with IT/OT, Quality Assurance, Manufacturing, System Owners, and Business Process Owners to ensure validation activities align with GMP requirements. • Develop validation strategies, risk assessments, traceability matrices, and testing plans. • Execute Computer System Validation (CSV) activities including IQ, OQ, PQ, UAT, and system qualification. • Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data Integrity requirements. • Support change controls, deviations, CAPA investigations, and audit readiness activities. • Manage testing execution, defect tracking, and validation deliverables throughout the project lifecycle. • Work with regulated systems such as MES, LIMS, SCADA, ERP, and electronic records systems. • Provide technical guidance on validation best practices and system compliance.

🎯 Requirements

• Bachelor's degree in Biomedical Engineering, Computer Science, Biology, Biochemistry, Chemistry, Biotechnology, Regulatory Affairs, Information Technology, or related Life Sciences field. • Minimum 5 years of experience in Computer System Validation (CSV) or Validation Engineering within a GMP-regulated environment. • Experience with Rockwell FactoryTalk PharmaSuite. • Strong knowledge of FDA, EMA, GxP, GAMP 5, and 21 CFR Part 11 requirements. • Experience authoring and executing validation protocols and test scripts. • Experience with risk assessments, change control, deviations, and CAPA processes. • Strong verbal and written communication skills. • Ability to work effectively in cross-functional teams.

🏖️ Benefits

• Medical • Dental • Vision • Paid Sick leave • 401K