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
activities
· 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
preferable.
· Advanced Therapeutics (Cell &
Gene Therapy) manufacturing experience is a positive.
· Aseptic operations experience is
preferable.
· 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.
Education
• Technical
Engineering qualifications (C&G or equivalent) at a minimum. Degree in a engineering
discipline or equivalent experience preferred.