Remote CSV Engineer - MedTech Validation & Compliance
BairesDev
Stand out for this role — generate a tailored resume and cover letter in about a minute.
Benefits offered by this job
Job summary
BairesDev in Chile is seeking a seasoned Computer System Validation (CSV) Engineer to ensure that regulated software and GxP systems meet industry standards. This hands-on role focuses on validating computerized systems, maintaining compliance, and safeguarding patient safety in MedTech environments.
You will author IQ/OQ/PQ protocols, manage test execution in Jira, perform data integrity assessments, and support system upgrades while working 100% remotely with flexible schedules and a global,
Qualifications
- 5+ years of experience in computer system validation (CSV).
- Background in GxP computerized systems validation.
- Familiarity with MedTech or medical device environments.
- Hands-on experience authoring IQ/OQ/PQ validation protocols.
Responsibilities
- Lead CSV activities for GxP computerized systems.
- Author and execute IQ/OQ/PQ validation protocols.
- Manage test execution and defect tracking through Jira.
- Conduct data integrity assessments across validated systems.
- Support system upgrades, migrations, and change control processes.
- Document validation evidence in line with regulatory standards.
Skills
Tools
Job description
BairesDev in Chile is seeking a seasoned Computer System Validation (CSV) Engineer to ensure that regulated software and GxP systems meet industry standards. This hands-on role focuses on validating computerized systems, maintaining compliance, and safeguarding patient safety in MedTech environments.
You will author IQ/OQ/PQ protocols, manage test execution in Jira, perform data integrity assessments, and support system upgrades while working 100% remotely with flexible schedules and a global,
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
