Drug Product Manufacturing or related cGxP manufacturing experience?
If interested, please forward your CV to * for
review or call *- * to
discuss in confidence.
MANUFACTURING SPECIALIST - ASEPTIC PROCESSES - BIOTECH - 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.
Contractors have a history of either extending their contract or being
offered permanent positions on this site.
The Project Engineer – New Syringe and AVI Lines Operations
Readiness will report to the Operational Readiness Programme Lead
within the Operations Function.
They will be responsible for providing project management and
engineering support for projects in the Operations Readiness Programme
for the new syringe and AVI lines.
Arrange agreement among the project team, customers, and management on
the goals of the project.
Work with workstream leads to develop and maintain the Project
schedule/plan that aligns with the overall goals of the Programme.
Effectively communicate with everyone involved in the project.
Have a controlled scope in place, which is understood by all
stakeholders and maintained throughout completion of the project.
Execute prudent risk and issue management.
Maintains Actions/Risk and Decision logs.
Generates and owns the GMP change control.
Motivate, support and direct project team members to deliver on
project plan.
Leads Team meetings and cross functional collaboration.
Works with resource managers from across the organisation to
effectively obtain and allocate resources to complete programs and
projects on time.
Compliance Related Tasks:
Always ensure compliance to cGMP
Ensure safety & compliance standards are maintained to the highest
standards.
Ensure financial compliance in line with Business & Financial
guidance.
Support a culture of personal responsibility within reporting
structure.
REQUIREMENTS
Technical Degree and/or Masters’ or equivalent
The successful candidate will have five to eight years of experience
within the pharmaceutical or biotech industry and will have
demonstrated project management skills.
Experience in a project engineering and management role in a
pharmaceutical or biotech manufacturing facility engaging with site
SMEs and managers along with global functions.
The ability to influence and lead cross functional teams to deliver
their projects that ensure a smooth start-up of the new vial filling
line.
The ability to work independently and identify risks and mitigation
pathways to ensure project deliver
A passion for continuous improvement applied to project management
Experience in a Life Science / Pharmaceutical / Biotechnology
Environment
Preferred Experience: Project Engineering & Management, Aseptic
Filling Line Operations, MES/EMBR, Validation, Greenfield / Brownfield
start up.
Systems / Equipment:
MS Office, MS Project, MS PowerPoint, and MS Visio,
Change Control & Document Management Systems
Preferred Requirements: Smartsheet
High Energy and Commitment
Ability to work independently.
Comfortable leading across multiple stakeholders & multinational teams
Strong ability to influence and affect change.
Capable of resolving issues of conflict effectively
Strong communicator
A proven track record to transfer goals and objectives into measurable
plans.
Ability to identify gaps/risks and put appropriate remediation plans
in place.
Uses strong relationships to identify requirements and potential
opportunities.
Employs project management techniques and Problem Solving
Provides leadership, guidance, and advice in own field of project
management.
Knowledge or experience with MES and EMBR projects
Knowledge or experience with validation of Aseptic Filling Lines
PACKAGE
Contract role. €0- €0 Per Hour
Min * month contract
We need : English (Good)
Type: Permanent
Payment: Pay: Negotiable
Category: Construction