Director, Engineering GMP/Lab Operations

1 day ago

Stevenage, United Kingdom Autolus Limited Full time

Role Summary
The Director, Engineering GMP/ Lab Operations is responsible for engineering operations relating to Autolus’ operations including, but not limited to, maintenance of equipment, instrumentation and calibration, asset life cycle management, maintenance scheduling, equipment validation, process engineering and building management engineering/systems. Managing a diverse team, you will work closely with the Director, Facilities & Capital Projects in relation to any facilities engineering or capital project activities across all our sites.

Key Responsibilities
  1. Facilities
    Oversight of all GMP engineering at Autolus’ Stevenage manufacturing operations. People management of maintenance and project engineering teams as well as any onsite contractor staff. This will include recruitment & training requirements.
    Ensure that all facilities and equipment are 100% operational and maintained in support for production, QC laboratory activities, and warehousing across all sites.
    Ensures our cGMP manufacturing facilities are properly maintained, calibrated, and documented to be compliant and appropriate for use. Serves as the primary facilities contact for regulatory and partner audits.
    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.
    Recommend solutions and implement appropriate corrective actions for major or complex maintenance issues using good documentation practices.
    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.
    Ensure 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.
    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.
    Proactively manage multiple, sometimes conflicting priorities with transparency and effectiveness, while seeking creative and viable solutions to resolve conflicts.
    Work alongside the Environmental Health and Safety department to ensure site processes, procedures and risk assessments are in place and appropriate.
    Provide management oversight of all engineering activities and provide performance data through KPIs and dashboards as appropriate to senior management.
    Represent Engineering and its associated activities during regulatory & statutory inspections.
    Ensure effective stakeholder management by maintaining clear communication, fostering relationships, and aligning project goals with stakeholder expectations.
    To perform other duties which are directed by the line manager.
Demonstrated Skills and Competencies

E – Essential P – Preferred

  1. Experience
    10 years’ experience in managing engineering operations in a highly regulated manufacturing industry. (E)
    Leadership experience within pharmaceutical, biologics or cell/gene therapy industries. (P)
    Experience with instrumentation, utilities, process engineering, maintenance, automation, computerized systems and validation activities in a GMP environment. (E)
    Experience managing external/3rd party vendors & contractors both remotely and in onsite operations. (E)
    GMP Experience (E)
  2. Qualifications
    BSc / BEng in Engineering or similar or equivalent training/experience in industry. (E)
    Master’s degree or MBA (P)
    Green belt or Black belt in Lean Six Sigma is a plus. (P)
  3. Skills/Specialist Knowledge
    Start-up Culture and Challenges – Demonstrated ability to lead and motivate a team in the face of ambiguity, lean resources, and multitasking requirements as in a start-up environment. Demonstrated ability to teach, work hands on when needed, and to lead by example from the front.
    Keeps up to date with current trends in the business environment.
    Impact and influence — Develops and maintains effective relationships (both internal and external) to facilitate necessary changes. Able to influence both above, peers and below in a matrix environment.
    Interpersonal effectiveness — Understand different points of view and resolve issues in a constructive manner. Able to operate effectively and comfortably in an international multicultural working environment.
    Leadership — Ability to attract, lead, manage and inspire talent and resources across the entire organization.
    Customer-centricity — Considers the impacts of all decisions on the customer, ensuring that any changes will improve and not impede customer service.
    Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures.
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