Engineering Manager

Autolus Ltd; Stevenage; On-site; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Performance bonus

Private medical insurance

Life assurance

Pension

Job summary

Autolus Ltd in Stevenage seeks an Engineering Manager (Shift) to lead a multiskilled team and maintain specialist pharmaceutical equipment supporting GMP manufacturing and QC operations.

The role involves planning reactive and preventive maintenance, coordinating with suppliers, and ensuring all activities comply with GDP, ALCOA and GMP standards while working on a rotating shift pattern.

Qualifications

• Bachelor of Science in Engineering or equivalent.
• Experience in regulated pharmaceutical or similar environment.
• Strong leadership and project management capabilities.

Responsibilities

• Lead and develop a multiskilled shift engineering team.
• Plan and execute maintenance and repairs on GMP manufacturing equipment.
• Ensure safe handover of equipment to production and maintain compliance with GDP/ALCOA/GMP.
• Coordinate with facilities, validation and capital projects as required.
• Drive continuous improvement and root cause analysis for equipment issues.

Skills

Team leadership

Regulated industry

Quality management

Project management

Equipment maintenance

Preventive maintenance

GMP knowledge

PLC control systems

CMMS

Equipment validation

Education

Bachelor of Science in Engineering

Tools

CMMS

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 private medical insurance, life assurance, and pension.

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

• 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 accommodations where appropriate.

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.

In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, and pension.