CAPA Engineer

Job Description: Manage CAPAs day to day, including investigations, corrections, action implementation, monitoring, and closure.

Take ownership of individual CAPAs and help accelerate the overall CAPA process.

Manage approximately 2 3 strategic CAPAs; a seasoned lead may manage 6 7 CAPAs while coordinating others conducting investigations.

Support quality system updates and modifications and ensure documentation compliance.

Provide guidance and coaching to additional CAPA personnel for the lead-level position.

Support the CAPA Chair for the lead-level position.

Work may include addressing approximately 80 90 standalone CAPAs and internal audit-related CAPAs.

Important Skills Needed:

CAPA management and processing experience, including leading investigations from initiation through closure.

Experience in controlled manufacturing environments, including laboratory and manufacturing operations.

Ability to assess product impact, develop corrective actions, implement them, and monitor effectiveness.

Ability to manage multiple CAPAs, drive collaboration, and learn processes quickly.

Experience with PLM systems.

Familiarity with MES, ERP, nonconformance, CAPA, audit, complaint, LIMS, maintenance, or environmental monitoring systems is relevant.

Strong communication, ownership, organization, and emotional intelligence.