Summary
Our client, a leading biopharmaceutical company based in East Cork, is seeking an experienced Senior Technical Services Engineer, to join their team.
The successful candidate will be responsible for supporting technical services activities associated with new product introduction (NPI), technology transfer, and lifecycle management of commercial products.
This role will act as a key interface between development and commercial manufacturing, ensuring alignment of technical activities with project timelines, regulatory requirements, and business objectives.
Responsibilities
This role will provide the strategic interface between the clinical manufacturing project execution team and the commercial manufacturing business unit to ensure the execution of the new product introduction activities are aligned to required timelines
Core responsibility to ensure the planning and execution of the new product introduction activities are aligned to the strategic vision and timelines for project including:
Leads a Matrixed team of personnel, organizing and executing project activities to ensure successful introduction of the product to the site
Responsible to ensure the new product introduction strategy and scope is aligned to the needs of the business.
Provide supervision of technical transfer activities associated with the new product introduction including project documentation creation and execution [e.g. Technology Transfer Protocol] and project task execution
Ensure all element of the new product introduction project are delivered on time within the stipulated scope and budget.
Managing relationships between clinical manufacturing team, receiving business unit and external parties such as formulation process development
Coordinate project updates to senior management where needed.
Support Commercial Product Life Cycle Activities on site including project management and technical transfer activity including:
Act as the primary technical interface between Development, Manufacturing, Quality, Regulatory, and Supply Chain teams for NPIs and ongoing product support.
Define and implement control strategies for new and existing products, ensuring robust process performance and compliance with cGMP and regulatory requirements.
Lead technical investigations of process deviations, complaints, and out-of-specification results, ensuring timely resolution and effective root cause analysis.
Develop and review master batch records, user requirement specifications, and validation protocols for new and existing products.
Provide expert technical support for troubleshooting, process optimisation, and the introduction of new technologies or analytical methods.
Liaise with contract manufacturers and external partners to ensure successful technology transfer and product launches.
Support the preparation and review of regulatory submissions and responses related to NPIs and commercial products.
Mentor and develop team members, supporting their career growth and technical development.
Ensure all activities comply with health, safety, and environmental regulations, and company policies.
Qualifications & Experience
Degree in a scientific discipline (e.g. Chemistry, Biochemistry, Biotechnology) or Engineering
Minimum 5+ years' experience in a pharmaceutical or biopharmaceutical manufacturing environment
Strong experience in technical services, technology transfer, and new product introduction
In-depth knowledge of manufacturing processes, process validation, and lifecycle management
Good understanding of cGMP regulations and regulatory requirements
Experience in cross-functional project management and stakeholder engagement
Proven ability to lead and develop teams in a matrix environment
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