knowledge of aseptic Drug Product manufacturing processes;
Parts/Components Preparation, Formulation, Syringe Filling, Vial
Filling, Lyophilisation and Capping?
This is a contract role based in Dun Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call *-**Apply
on the website** to discuss in confidence.
OPERATIONS LEAD- BIOTECH NPIS - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing
plant.
Operations Lead will serve as primary production process owner
responsible for New Product Introduction, Life Cycle Management
Projects and/or CAPEX projects and established process improvements
projects.
This role requires in-depth technical and operational knowledge of
aseptic Drug Product manufacturing processes; Parts/Components
Preparation, Formulation, Syringe Filling, Vial Filling,
Lyophilisation and Capping.
They will be the operations point of contact for coordination of the
manufacturing effort and will be responsible for driving process
efficiencies as part of the project for operations.
They will apply process, operational, scientific expertise, basic
compliance knowledge, and analytical and troubleshooting skills to
ensure streamlined manufacturing operations are enabled in both vial
and syringe facilities.
Function as the site interface between the Product Delivery Teams
(PDT’s), and ADL Manufacturing operations.
Engaging with staff members within the Manufacturing department to
ensure understanding of the processes and working collaboratively
cross functionally with Facilities & Engineering, Quality, PD and
Supply Chain.
Develop, review, and approve Generic Master Batch Records and
Parameter Value Lists across Formulation, Filling and Inspection
Develop, review and update Production, Engineering, Operating
Procedures & training materials
Assist in providing training on scientific or technical aspects of the
current process/project(s) to Direct Manufacturing
Evaluate, plan, and implement solutions for process improvement
opportunities both current and project related.
Support scheduling and execution of Characterisation, Engineering and
PPQ runs, ensuring all necessary pre-requisites are included on the
schedule and assess process performance by observation of floor
operations and review of performance data
Provide troubleshooting support throughout the project and on the
floor during execution of activities
Hold people to account for delivery and behaviors within the
Manufacturing Support team and associated with the project(s)
Perform Job Hazard Assessments and Change Control Assessments to
determine impact to Manufacturing
Partner with Learning & Performance to define training strategies for
current processes, NPIs and complex projects
Consult with Quality Assurance to ensure that GMP standards are
maintained in line with current SOP’s, batch documentation and
licences
Develop, review and update Protocols for manufacturing activities
Documentation and approval of protocol deviations for manufacturing
activities
Consult with Process Development, Direct manufacturing, Equipment, and
System Owners regarding process changes in an effective and timely
manner
Own and lead change controls as required by the Manufacturing support
team
Review and approve Bills of Materials
Develop, review and update Product Quality Risk Assessments
REQUIREMENTS
Bachelor’s degree in a science discipline.
3+ years of biopharmaceutical manufacturing experience in Fill Finish
or related manufacturing or GMP experience in the pharmaceutical or
medical device industry.
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products.
Strong Project Management and organizational skills, including ability
to follow assignments through to completion
Critical thinking skills: Gathers data from key stakeholders, analyses
and interprets information to develop solutions to technical problems
of moderate complexity
Negotiation and Influencing skills
Take initiative to identify and drive improvements
Excellent verbal and written communication skills: Strong Technical
writing skills for GMP documentation (e.g., investigations,
procedures, change controls) and good Presentation skills
Escalate issues professionally and in a timely manner
Decision Making skills and confidence to challenge others on decisions
that impact the manufacturing area
Teamwork and Coaching others
Ensures compliance within regulatory environment
Demonstrated ability to work independently and deliver right
first-time results under minimal direction
PACKAGE
Contract role
Hourly Rate € per hour negotiable
Minimum * month contract
4-day on-site requirement
SHIFT PATTERNS & ON-CALL OPPORTUNITIES:
Now they have a lot of PPQ activities coming up due to the new vile
line we’ll be asking for volunteers for a 3-to-4-week period for the
PPQ’s.
There will be volunteers to go on the two-cycle shift pattern & then
the other ask is, if you’re not going on the shift pattern can you
do on-call for the weekends.
People required to go on a two-cycle shift pattern for the duration of
each PPQ activities:
8-hour days operating over a 5 day week (Monday – Friday).
2-week rota.
Week 1 Morning Shift: *:**Apply on the
website** – *: * (Mon
– Thurs) *: * –
*: * (Fri).
Week 2 Evening Shift: *:**Apply on the
website** – *: * (Mon
– Thurs) *: * –
*: * (Fri).
Alternating pattern, so if on morning shift week 1 then on evening
shift week 2 and so on.
*% shift premium applied.
ON-CALL
On-call cover for weekends from *:**Apply on
the website** Saturday – *:**Apply on the
website** Sunday (excluding nights).
Rostered on-call.
Must be able to attend site if required over both days.
We need : English (Good)
Type: Permanent
Payment: Negotiable
Category: Construction
