Job Description

Autolus is seeking a highly motivated

Operator II

to join our GMP manufacturing team. This

shift-based role

involves weekend working and operates across

6 AM - 10 PM

. You will play a key role in ensuring the production of high-quality cell-based products while maintaining compliance with GMP regulations, safety standards, and company procedures.


###

Key Responsibilities

As an

Operator II

, you will:


Execute production processes and operate associated equipment in line with

GMP and GDP

requirements. Maintain cleanroom environments through

sterile room maintenance, hydrogen peroxide vapour gassing, and environmental monitoring (EM).

Conduct

raw material transfers, particulate cleaning and disinfection, material receipt, and drug product shipment.

Accurately complete documentation and data entry, ensuring compliance with regulatory standards. Perform

cell culture activities

including sampling, counting, washing, activation, feeding, harvesting, and

magnetic enrichment/depletion (MACS).

Carry out

aseptic manipulations in Grade A environments

and meet associated

BROTH qualification (OAQ) standards.

Support batch review execution and

collaborate with cross-functional teams

to ensure smooth workflow. Lead or support

operational deviations, process risk assessments, and continuous improvement (CI) initiatives.

Assist in the authoring and revision of

SOPs, SWIs, and risk assessments

to maintain process efficiency and compliance. Provide guidance and mentoring to junior team members, supporting their training and development.
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Skills & Experience

Minimum 2 years

of GMP manufacturing cleanroom experience (essential). Experience working in

shift-based, high-performance environments

(preferred). Strong understanding of

GxP, ATMP production, QMS, and environmental health & safety requirements.

Ability to follow detailed instructions, work with

attention to detail

, and make

quality-critical decisions

. Proficiency in

Microsoft Office (Word, Excel, Teams, PowerPoint)

and familiarity with problem-solving methodologies like

Lean Six Sigma

(preferred). Excellent

communication, teamwork, and organizational skills.

###

Working Pattern

This is a

shift-based role

requiring

weekend work

. Shifts will fall within the operational hours of

6 AM - 10 PM

.

This role offers an exciting opportunity to be part of an

innovative biotech company

, contributing to the manufacture of next-generation cell-based therapies. If you're passionate about GMP manufacturing and eager to make a difference, we'd love to hear from you!