Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Role Summary
* The Engineering Manager will be responsible for maintaining specialist pharmaceutical equipment and facility installations to support our manufacturing and QC operations.
* They will be primarily responsible for the shift team supporting equipment breakdown repairs & on-going maintenance work of manufacturing equipment and associated utility systems.
* They will plan and complete a range of reactive & planned maintenance works associated within the GMP facility & lab as well as order and maintain critical spares.
* The role will be shift based.
Key Responsibilities
* Leadership of a multiskilled engineering team.
* Own and actively progress teams work load and professional development.
* Responding to fast paced and complex equipment needs.
* Lead and structure problem solving to diagnose faults and repair of equipment breakdowns.
* Foster continuous improvement mind set, focus on root cause, elimination actions.
* Represent Engineering Dept at multi departmental meetings.
* Work with equipment suppliers planning for and during major maintenance activities
* Ensuring equipment is handed back to production in 100% safe condition.
* Conducting risk assessment prior to any maintenance work.
* Verifying GDP, ALCOA, GMP and GEP practices are followed in CMMS
* Creating maintenance procedures (Including writing SOPs).
* Managing contractors and their activities.
* Providing support to Facilities, Validation and Capital Project Engineering as required.
* Provide SME support to other business functions.
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
* Team leadership experience (E)
* 3 years of working within a clean room or regulated environment. (P)
* Working in a Pharmaceutical or other heavily regulated industry. (E)
* HVAC, compressed gases, and integrated control systems knowledge. (P)
* Operating within the requirements of a Quality Management system. (E)
* Project management experience. (P)
* Equipment validation lifecycle knowledge. (P)
* Control system (PLC) experience. (E)
* CMMS experience (E)
* Experience of managing and performing planned preventive maintenance. (E)
* Experience in GMP standard quality management systems (i.e. CAPAs, CCs & Deviations) (E)
Qualifications
* Bachelor of Science – Relevant engineering degree or HNC/D with relevant experience.
Skills/Specialist knowledge
* Working with small/medium scale manufacturing and analytical equipment.
* Pharmaceutical utility systems and controls.
* BMS and EMS.
* Clean room operations.
* Computer literate - Microsoft Office suite.
* Knowledge and expertise in small scale pharmaceutical manufacturing equipment. (P)
* Knowledge of current standards, procedures, and controls for GMP cleanroom facilities and equipment. (P)
* Knowledge and expertise in utility systems from HVAC to medical gasses etc. (E)
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