Lab Equipment Validation SME

We are in Critical need of Lab Equipment Validation SME for Long Term Role in WALTHAM MA .

Role : Lab Equipment Validation SME

Location : WALTHAM MA

Duration : Long Term

Job Description :

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.