Director of Engineering Operations
3 weeks ago
Job Title: Director, Engineering GMP/Lab Operations
About the Role:
Autolus Limited is seeking a highly skilled and experienced Director, Engineering GMP/Lab Operations to join our team. As a key member of our leadership team, you will be responsible for leading our engineering operations in a highly regulated manufacturing environment.
Key Responsibilities:
- Facilities: Oversight of all GMP engineering at Autolus' Stevenage manufacturing operations.
- People Management: People management of maintenance and project engineering teams as well as any onsite contractor staff. This will include recruitment & training requirements.
- Maintenance and Calibration: Ensure that all facilities and equipment are 100% operational and maintained in support for production, QC laboratory activities, and warehousing across all sites.
- Regulatory Compliance: Ensures our cGMP manufacturing facilities are properly maintained, calibrated, and documented to be compliant and appropriate for use. Serves as primary facilities contact for regulatory and partner audits.
- Problem-Solving: Lead teams that resolve and repair facility support systems safely and expeditiously, start up and shutdown facility systems, maintain up to date records for all country and local requirements.
- Process Improvement: Recommend solutions and implements appropriate corrective actions for major or complex maintenance issues using good documentation practices
- Collaboration: Work with Executive Director, Facilities, Engineering & Capital Projects to establish the GMP engineering group systems and programs and establish optimization strategies, operational budget planning and collaboration / support for wider engineering projects.
- Regulatory Compliance: Ensuring compliance with cGMP and all other pertinent governmental regulations in the execution of and record keeping for all maintenance and calibration activities on the site.
- Vendor Management: In collaboration with the relevant site customer(s) and Strategic Sourcing and Procurement, drive vendor selection, management, and resource optimization for equipment maintenance and servicing.
- Communication: Proactively manages multiple, sometimes conflicting priorities with transparency and effectiveness, while seeking creative and viable solutions to resolve conflicts.
- Stakeholder Management:
- Representative: Works alongside the Environmental Health and Safety department to ensure site processes, procedures and risk assessments are in place and appropriate.
- Reporting: Provide management oversight of all engineering activities and provide performance data through KPIs and dashboards as appropriate to senior management.
- Representation: Represent Engineering and its associated activities during regulatory & statutory inspections.
- Customer Focus: Ensure effective stakeholder management by maintaining clear communication, fostering relationships, and aligning project goals with stakeholder expectations.
Requirements:
- Experience: 10 years' experience in managing engineering operations in a highly regulated manufacturing industry.
- Leadership Experience: Leadership experience within pharmaceutical, biologics or cell/gene therapy industries.
- Skills and Qualifications: BSc / BEng in Engineering or similar or equivalent training / experience in industry. Green belt or Black belt in Lean Six Sigma a plus.
What We Offer:
At Autolus Limited, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you
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