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Val SME Lab equipment validation

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
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
Position: Val SME for Lab equipment validation
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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