Val SME for Lab equipment validation

yochanaWaltham, MASenior L5

Job Title

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.

Matching similar jobs

Level

Senior L5

Location

Waltham, MA

Occupation

Validation Engineers

Industry

Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables

Posted

today