Validation Engineer: Laboratory and Manufacturing Equipment

At-a-Glance:
re you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a Validation Engineer: Laboratory and Manufacturing Equipment.

Position Type:

• Contract
• Onsite

Required

• Experience as Validation Engineer: Laboratory and Manufacturing Equipment.

Responsibilities:

• Authoring and execution of Commissioning test plans (CTP) for new and modified systems/equipment including Chromatography skids, Temperature Controlled units, Ultrafiltration/Diafiltration Skids, Totes, columns and bioreactors.
• Authoring Installation, Operational, and performance Qualification (IOPQ) protocols per Food and Drug Administration (FDA)/ company guidelines.
• Drafting, reviewing, receipt and addressing of comments to approve validation documentation in compliance with FDA and company guidelines.
• Validate laboratory and manufacturing equipment and processes such as Chromatography systems, Stability System, Empower, Soft Max Pro, Incubators, Spectrophotometers, Plate Readers, Autoclaves and other equipment.
• Execution of approved protocols per company Good Documentation Practice (GDP) Current Good Manufacturing practice (cGMP), and applicable current industry guidance.
• Study new product characteristics based on process transfer protocols and define validation deliverables/strategy for all impacted procedures in the product manufacturing lifecycle.
• Draft validation project/master plans, including roles and responsibilities, and testing strategies.
• Develop project plan summary reports to maintain and track all associated validation protocols, reports, and engineering test plans with change control records.
• Identifies discrepancies that have occurred during execution of IOPQ protocols during manufacturing and laboratory equipment qualification.
• Identifies impact of the discrepancies on protocol, equipment, or product.
• Perform failure analysis processes and documentation for discrepancies.
• Review manufacturing operational use SOPs that apply to validated equipment and processes.
• Review master batch records to ensure alignment with specified procedures and
• process transfer protocols.
• Draft and review technical specifications including user requirement specifications (URS) and Functional Requirement Specification (FRS).
• Perform Parameter mapping studies for applicable units to gauge performance and gather necessary data.
• Based on study data, suggest mitigation efforts for potential safety issues and deviations.
• Based on scientific data analysis, develop risk-based approaches for future studies and challenge the status quo to increase operational efficiency.
• Perform calibration activities and maintain the equipment logs for the equipment to use in validation activities and verify the calibration data for the equipment.
• Manage, review/approval process for validation documents in company electronic document repository and ensure detailed logs books are maintained for audit readiness.