More jobs:
Val SME Lab equipment validation
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-06-01
Listing for:
Yochana
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Key Responsibilities:
• Validation Plan Development:
Creating comprehensive validation plans that outline the steps for verifying equipment performance.
• Risk Assessment:
Identifying and assessing potential risks associated with using the equipment.
• IOQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification):
Conducting these essential tests to verify equipment installation, functionality, and performance under normal operating conditions.
• Data Analysis and Reporting:
Analyzing validation data and preparing reports to document findings and ensure compliance.
• Documentation:
Maintaining detailed records of validation activities, including validation protocols, reports, and SOPs.
• SOP Development:
Developing and maintaining Standard Operating Procedures for equipment operation and maintenance.
• Calibration and Maintenance:
Ensuring equipment is calibrated and maintained according to established procedures.
• Troubleshooting:
Identifying and resolving issues related to equipment performance.
Skills and
Qualifications:
• Technical Knowledge:
Strong understanding of laboratory instrumentation, validation principles, and relevant regulations.
• Analytical
Skills:
Ability to analyze data, identify trends, and interpret results.
• Problem-Solving
Skills:
Ability to identify and resolve technical issues.
• Documentation
Skills:
Strong written communication and report writing skills.
• Attention to Detail:
Accuracy and meticulousness in recording data and documenting findings.
• Good Communication
Skills:
Ability to effectively communicate with colleagues and stakeholders.
•
Experience:
Relevant experience in a laboratory environment, ideally with experience in instrument validation or related roles.
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