Multi-Skilled Engineer II

Autolus Therapeutics; Stevenage; On-site; GBP 52,000 - 70,000; Full time

Job summary

Autolus Therapeutics in Stevenage seeks a Multi-Skilled Engineer II to maintain pharmaceutical equipment and facilities to support GMP manufacturing and QC operations. The role is shift-based with early and late schedules on a rotating basis across 2 on-2 off, 3 on-2 off, 2 on-3 off.

You will diagnose faults, perform preventative maintenance, and manage spares while working within a regulated environment. A BS in engineering and hands-on maintenance experience are required.

Qualifications

• 3 years of working within a clean room and regulated environment.
• Experience in GMP quality management systems and validation lifecycle.
• Project management experience is a plus.
• Experience in managing and performing planned preventive maintenance.

Responsibilities

• Respond to faults and repair equipment breakdowns.
• Repair and improve equipment issues.
• Ensure equipment is handed back to production in safe condition.
• Conduct risk assessments prior to maintenance work.
• Complete breakdown and repair reports.
• Plan and undertake scheduled maintenance.
• Create maintenance procedures (SOPs).
• Manage contractors and their activities.
• Provide support to Facilities, Validation and Capital Project Engineering as required.
• Maintain stocks of critical engineering spares and equipment.

Skills

Maintenance engineering

GMP compliance

HVAC systems

Electrical troubleshooting

Education

Bachelor of Science – Relevant engineering degree

Tools

CMMS

PLC

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: Multi-Skilled Engineer II

Reports to Manager, Shift 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 Multi-skilled Maintenance Engineer will be responsible for maintaining specialist pharmaceutical equipment and facility installations to support our manufacturing and QC operations.
• They will be primarily responsible for 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

• Responding to & diagnosing faults and repair of equipment breakdowns.
• Repairing & improving other equipment issues.
• Ensuring equipment is handed back to production in 100% safe condition.
• Conducting risk assessment prior to any maintenance work.
• Completing breakdown & repair reports.
• Planning and undertaking scheduled maintenance.
• Creating maintenance procedures (Including writing SOPs).
• Managing contractors and their activities.
• Providing support to Facilities, Validation and Capital Project Engineering as required.
• Managing stocks of critical engineering spares and equipment.
• Maintaining an engineering workshop.
• Providing operator training as necessary.
• Using manuals and failure history to develop preventative tasks.
• Provide SME support to other business functions.
• Deputising in other roles as required.

Demonstrated skills and competencies

E – Essential

P – Preferred

Experience

• 3 years of working within a clean room and 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.