Drug Product Operational Readiness Lead - Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid - 3 days onsite
Pay: €90 - €110 per hour
Experience: 8+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, 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.
e are seeking an Operations Readiness Lead to play a pivotal role in ensuring "right-first-time" and "on-time" startup readiness.
Reporting to the Director of Manufacturing, the Operations Readiness Lead will help shape the manufacturing landscape by developing and implementing robust processes, systems, and readiness activities aligned with best practices from the company network and industry benchmarks.
Lead cross-functional planning and execution of the Operations Readiness roadmap, from facility design through to PPQ (Process Performance Qualification).
Collaborate with capital project team as well as site operations functions such as engineering, quality, process development and EHSS teams to design and lead various operational readiness workstreams such as optimal material and process flows, materials requirements for testing and qualification activities, documentation such as operating philosophy that serve as inputs to detailed design of facility and equipment etc for a new aseptic facility.
Develop and maintain a readiness timeline identifying key milestones, dependencies, and resource needs.
Able to perform and lead Gap analysis documentation on site and network practices and drive any mitigation actions to close the gaps. Facilitate risk assessments and mitigation strategies tied to operational readiness and manufacturability.
Coordinate and lead the development of operational procedures, and batch records to support GMP-compliant, efficient startup.
Serve as the voice of manufacturing operations within cross-functional startup and tech transfer teams, bringing a practical, floor-focused lens to facility and process design.
Drive continuous improvement initiatives to optimize operational performance and reduce variability during startup.
Requirements
Bachelor's Degree in Engineering or Relevant Experience
8+ years of experience in biopharma operations, with significant exposure to aseptic manufacturing, sterile drug product filling, and startup or capital projects environments.
Proven ability to lead cross-functional teams and projects in a matrixed, fast-paced environment.
Strong knowledge of GMP regulations and practices particularly related to sterile fill-finish processes.
Excellent communication and organizational skills, with a demonstrated ability to self-start and manage ambiguity in a greenfield or brownfield setting.
Experience in developing and deploying SOPs, batch records, and training documentation.
Prior involvement in facility design, commissioning, or startup of drug product operations.
Experience working with automation and high-speed filling lines for syringes.
Experience within a global pharma manufacturing network is a plus.
Package
Contract role - Hourly rate €90 - €110 per hour
Minimum 12 month contract with the possibility of an extension.
At least three days per week is the onsite expectation as this is for a large Capital Project.