Validation and QA Specialist 1

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.

• Strategic objective: build a strong Validation Team to enable successful product transfers; works closely with Production, Maintenance, and cross-functional teams; engages with suppliers and service providers.

• Candidates must have direct implementation experience and ownership of validation activities.

Who You Are: