Engineering Manager

Autolus Therapeutics; Stevenage; On-site; GBP 70,000 - 90,000; Full time

Job summary

Autolus Therapeutics is seeking an Engineering Manager (Shift) in Stevenage to lead a multiskilled engineering team within our GMP manufacturing and QC facilities. The role involves owning maintenance activities, driving improvements, and ensuring equipment is maintained to GMP/GDP standards between 600AM–2300PM rotations.

The successful candidate will have a strong background in regulated environments, PLC/BMS control systems, and proven leadership in shift-based operations, with a focus on

Qualifications

• Degree or equivalent in engineering or sciences with strong GMP understanding.
• Experience leading engineering teams in a regulated pharmaceutical setting.
• Proven track record in preventive and corrective maintenance planning.

Responsibilities

• Lead multiskilled engineering team and manage workloads.
• Coordinate maintenance and repairs for manufacturing equipment and utilities.
• Define and implement maintenance procedures and SOPs.
• Ensure safe return of equipment to production and conduct risk assessments.

Skills

Leadership

Shift management

GMP/QA knowledge

CMMS

PLC control systems

Risk assessment

Project management

HVAC/Utilities

Education

Bachelor of Science – Engineering

Tools

CMMS

PLC

BMS/EMS

Job description

Work with us
Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.

Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Job Description

Job Title: Engineering Manager (Shift)

Reports to: Associate Director, Engineering

Department: Engineering

Hours: Shift Working: 2 on- 2 off, 3 on - 2 off, 2 on 3 off.

This will rotate across earlies and lates every 14 days. Early shift: 600AM to 1600PM; late shift:1100AM to 2300PM.

Location: Stevenage

About Autolus

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

Why Autolus

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package.

Our Promise

Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.

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)

Autolus Core Competencies

Focus on Results: Works to meet business goals set by management and leaders

Builds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments

Resilience: Has the capacity to recover quickly from difficulties; toughness

Communicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR)

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodationswhereappropriate.

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.