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.
· 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.
maintenance SME within the Drug Product Aseptic Operations team.
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.
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.
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 &
maintenance procedures and Engineering Work Instructions (EWIs), and other
relevant documentation, where required.
training to colleagues as per site training procedures.
equipment spares holding levels and make changes post review.
· Any other
maintenance related activities as directed by the Operations Lead
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.
Engineering qualifications (C&G or equivalent) at a minimum. Degree in a engineering
discipline or equivalent experience preferred.