Engineering Lead for GMP Operations
2 months ago
Role Summary
Autolus Limited is seeking a highly motivated and experienced Engineering Lead to oversee all aspects of engineering operations within our GMP manufacturing facilities. This role will play a crucial part in ensuring the smooth and efficient operation of our production, quality control (QC) laboratory activities, and warehousing across all sites.
Key Responsibilities
- Facilities Management: Provide comprehensive oversight of all GMP engineering activities at Autolus' manufacturing operations. This includes managing maintenance and project engineering teams, as well as any onsite contractor staff.
- Equipment & Systems Maintenance: Ensure that all facilities and equipment are fully operational and maintained to support production, QC laboratory activities, and warehousing across all sites. Implement robust calibration and documentation procedures to ensure compliance with cGMP regulations.
- Regulatory Compliance: Serve as the primary point of contact for regulatory and partner audits related to GMP engineering practices. Lead teams in resolving and repairing facility support systems promptly and safely, adhering to all relevant country and local requirements.
- Project Management & Collaboration: Work closely with the Executive Director, Facilities, Engineering & Capital Projects to establish engineering group systems and programs. Collaborate on optimization strategies, operational budget planning, and support for wider engineering projects.
- Vendor Management: In collaboration with Strategic Sourcing and Procurement, drive vendor selection, management, and resource optimization for equipment maintenance and servicing.
Demonstrated Skills & Competencies
- 10+ years of experience managing engineering operations in a highly regulated manufacturing industry.
- Proven leadership experience within the pharmaceutical, biologics, or cell/gene therapy industries.
- Extensive experience with instrumentation, utilities, process engineering, maintenance, automation, computerized systems, and validation activities in a GMP environment.
- Experience managing external vendors and contractors both remotely and onsite.
- Strong understanding of cGMP regulations and best practices.
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