Apply to Sr. Quality Application Specialist (Science)/ Sr. Quality Engineer (Engineer)

Key Requirements:

Bachelor's degree in Engineering or Science.
Knowledge and experience with IT systems and integrations with manufacturing equipment.
Minimum of 4 years of experience in Quality Systems, Computer System Validation (CSV), or regulated IT environments.
Strong expertise in CSV lifecycle management.
Experience authoring and reviewing validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, reports, and SOPs.
Knowledge of FDA, GxP, ISO, and data integrity requirements.
Experience managing documentation changes and change control processes.
Strong quality and compliance leadership skills.
Excellent cross-functional communication and stakeholder management abilities.

Preferred Qualifications:

Experience with electronic Quality Management Systems (QMS) such as Trackwise, ETQ, Master Control, or Veeva.
Experience supporting regulatory audits and inspections related to computerized systems.

Work Methodology: