Overview
Senior Validation Specialist Jobs in Baltimore, Maryland, USA at Cogent Biopharma
**
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for Lab Ware LIMS.
Independently create and maintain validation documentation, ensuring compliance with FDA, GMP, GLP, and ISO requirements.
Conduct comprehensive risk assessments and impact analyses to determine effective validation strategies.
Collaborate closely with Quality Assurance, IT, and laboratory teams to align validation procedures with industry standards and organizational goals.
Troubleshoot and resolve validation issues related to Lab Ware LIMS, ensuring minimal disruption to operations.
Stay updated on industry best practices, regulatory requirements, and advancements in Lab Ware LIMS technology.
Provide training and mentorship to junior team members on validation processes and Lab Ware functionality.
Support audits and regulatory inspections by providing thorough validation documentation and timely responses.
*** Bachelor’s degree in Computer Science, IT, Life Sciences, or a related field (Advanced degree preferred).
***** Minimum of 5+ years of hands-on Lab Ware LIMS validation experience in a regulated environment.
Proven ability to independently develop and execute validation protocols and reports.
Strong knowledge of regulatory requirements (FDA, GMP, GLP, ISO) pertaining to LIMS validation.
Excellent analytical, problem-solving, and documentation skills.
Ability to manage multiple priorities effectively in a fast-paced environment.
Experience with validation lifecycle management and change control processes.
Familiarity with other laboratory systems and software is advantageous.
Preferred **
Lab Ware LIMS certification or relevant validation certifications.
Experience in regulated industries such as pharmaceuticals, biotechnology, or healthcare.
Application *
* If you are a seasoned Lab Ware validation expert seeking an exciting opportunity to lead validation efforts in a growing organization, we invite you to apply for this contract position. Please submit your resume and cover letter.
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Title: Senior Validation Specialist
Company: Cogent Biopharma
Location: Baltimore, Maryland, USA
Category: Quality Assurance – QA/QC, Healthcare
