Job Description

Position Summary

A key member in
supporting the execution of operational readiness in VLE therapeutics  manufacturing facility. The manufacturing
associate will become SME in a number of unit operations throughout the process
and is responsible for executing batch operations as per standard operating
procedures under limited supervision.

Principal Responsibilities

·       Demonstrate high performance
behaviours, ability to work collaboratively within a cross functional team,
ability to show independent initiative, to have a focus on continuous
improvement and have a strong belief in supporting the right culture in the business.

·       Equipment
maintenance SME within the Drug Product Aseptic Operations team.

·       Perform
preventative and corrective maintenance of process equipment in Drug Substance
Facility in accordance with cGMP and Good Engineering Practices (GEP).

·       Active member
of Operations team who will monitor line performance during batch processing
and respond to equipment issues to minimize equipment downtime.

·       Troubleshoot
equipment issues e.g. mechanical, electrical, automation, instrumentation
issues within manufacturing facility.

·       Ensure that
all work carried out and equipment installed is safe, effective and in
compliance with the appropriate industry standards.

·       Ensure that
maintenance activities are completed in compliance with Site Engineering
policies and procedures.

·       Ensure that
all work undertaken is reflected accurately in Work Order documentation and/or
up to date Engineering / project information files.

·       Liaise with
Engineering & manufacturing team to plan and execute planned preventative
maintenance including review of drawings, OEM manuals and identification of
required spare parts

·       Liaise with
and support the area Senior Engineer to escalate significant equipment issues,
prioritise corrective maintenance between batches and to plan identified CI

·       Support the
development, commissioning & qualification e.g. Site Acceptance Testing of
a new vaccines drug product manufacturing equipment and subsequent transition
to commercial manufacturing.

·       Participate
and support the following processes: Total Productive Maintenance (TPM),
Continuous Improvement (CI), 5S, defect walk downs, 5S and quality
investigations relating to equipment.

·       Own individual
CI projects as identified through equipment data analysis via TPM &
supported by Operations Lead

·       Review and
approve work executed by external contractors such as OEM suppliers &
service providers.

·       Review/prepare
maintenance procedures and Engineering Work Instructions (EWIs), and other
relevant documentation, where required.

·       Provide
training to colleagues as per site training procedures.

·       Review
equipment spares holding levels and make changes post review.

·       Any other
maintenance related activities as directed by the Operations Lead

·       Support
Manufacturing team to consistently deliver on specific area Key Performance
Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment
Effectiveness (OEE), and team training.

·       Perform role
of Shift Lead Designee as required

Experience & Qualifications

·       More than 5 years’ experience in cGMP
Pharmaceutical Operations is essential.

·       More than 5 years’ experience in Drug
Substance Biologics manufacturing is essential.

·       Vaccine manufacturing experience is

·       Advanced Therapeutics (Cell &
Gene Therapy) manufacturing experience is a positive.

·       Aseptic operations experience is

·       The role may operate on rotating shift position
and may also involve some non-scheduled call-in time to respond to plant
emergencies etc. and some scheduled call-in time to attend process operations.          

·       Demonstrated experience in the maintenance, repair
and troubleshooting of complex equipment including one or more of electrical,
automation and mechanical issues is required.

·       Demonstrated ability to use problem solving tools
within a team environment such as 5 Whys, DMAIC e.g. Method 1 is desirable.

·       Due to the start-up nature of the project there
will be an expectation for flexibility and an ability to take on varied tasks
at short notice not covered extensively within this job description.

·       Must be able to read, write and
converse in English.

·       Must have good working knowledge of
MS Excel and Word

·       Excellent interpersonal skills, positive influence,
team orientation, attention to detail, documentation skills, problem
identification and problem-solving skills

·       An ability to work independently, and as a member
of a self – managed shift team in a dynamic, fast-paced environment that
requires flexibility and initiative.

• Technical
Engineering qualifications (C&G or equivalent) at a minimum. Degree in a engineering
discipline or equivalent experience preferred.