Sr Director Engineering Validation Maintenance
Overview
Strategic leader overseeing engineering validation maintenance and automation for sterile pharmaceutical manufacturing. Drives end-to-end lifecycle ownership of facility utility manufacturing and automation systems ensuring regulatory compliance operational excellence and business continuity.
What You'll Do11
- 1Lead engineering validation maintenance reliability and automation programs supporting operations and future growth
- 2Oversee validation activities including commissioning qualification and requalification programs
- 3Manage site maintenance metrology and reliability engineering to maximize uptime and reduce risk
- 4Provide leadership for manufacturing automation and digital infrastructure including PLCs SCADA and historians
- 5Drive automation and digital transformation initiatives improving process robustness data integrity and scalability
- 6Develop and execute long-range capital and infrastructure strategies aligning with business objectives
- 7Foster culture of safety quality compliance and continuous improvement through talent development and coaching
- 8Represent department on leadership teams client meetings audits and cross-functional initiatives
- 9Establish departmental goals KPIs and strategic plans supporting operational excellence objectives
- 10Direct metrology function ensuring calibration maintenance and lifecycle management of critical instruments
- 11Lead business continuity planning disaster recovery and risk mitigation strategies
Requirements5
- 15+ years building ETL pipelines with Spark and Airflow
- 215+ years related experience
- 36+ years people leadership experience
- 4Prior pharmaceutical experience required
- 5Knowledge of cGMP regulations FDA EU GMP Annex 1 ICH ISPE ASTM and industry best practices
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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