Director of Engineering Operations

3 weeks ago


Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

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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