Validation and QA Specialist 1

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

• Identify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility.

• Demonstrated hands-on experience in preparing, executing, and managing IQ/OQ/PQ protocols across equipment, systems, facilities, utilities, and manufacturing or testing processes in a cGMP environment.

• Coordinate and support cleanroom qualification, facility and utility qualification activities; create and govern the Validation Master Plan (VMP); review, approve, and maintain validation protocols, SOPs, and technical documentation in a controlled, compliant manner (cGMP, GAMP 5, FDA 21 CFR Part 11, ISO 9001).

• Identify and assess validation changes, deviations, and CAPAs; ensure remediation and closure of compliance actions; conduct risk assessments (FMEA, impact assessments); perform trend analysis of non-conformances and data reviews; ensure QMS conforms to ISO 9001 and organizational policies; lead audits and regulatory inspections; drive root cause analysis and timely closure of corrective actions; collaborate with cross-functional teams to drive validation deliverables.

• Acts as the site validation owner, quality face to customers; performs process audits to identify gaps and implement corrective actions; supports technology transfer and global projects; stays current with industry regulations and trends; supports EHS/OSHA as required; operates in a multi-cultural, multi-time-zone environment; demonstrates strong networking and problem-solving skills to influence across organizational levels.