What are the responsibilities and job description for the Senior Validation Specialist position at Cogent Biopharma?
Key Responsibilities:
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for LabWare 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 LabWare LIMS, ensuring minimal disruption to operations.
- Stay updated on industry best practices, regulatory requirements, and advancements in LabWare LIMS technology.
- Provide training and mentorship to junior team members on validation processes and LabWare functionality.
- Support audits and regulatory inspections by providing thorough validation documentation and timely responses.
Qualifications:
- Education: Bachelor’s degree in Computer Science, IT, Life Sciences, or a related field (Advanced degree preferred).
- Experience: Minimum of 5 years of hands-on LabWare 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 Qualifications:
- LabWare LIMS certification or relevant validation certifications.
- Experience in regulated industries such as pharmaceuticals, biotechnology, or healthcare.
- Project management experience.
Benefits:
- Competitive compensation package commensurate with experience.
- Opportunity to work with cutting-edge technology in a dynamic and collaborative environment.
- Professional development opportunities and career growth potential.
Application Process: If you are a seasoned LabWare 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.
