Technical Operations Lead

Terumo BCT is a Global leader in blood management, blood safety, therapeutic apheresis, cell therapy and cell collections. We have an exciting opportunity for a Technical Operations Lead to join Terumo BCT
- Larne. Come join us today!

The successful candidate will support and enhance our sterile IV bag manufacturing operations, drive compliance, technical excellence, and continuous improvement across our commercial manufacturing processes. They will serve as the primary technical liaison between Production, Quality, and Engineering, with ownership of QMS-related activities and operational improvement initiatives. This role requires a strong foundation in GMP compliance, sterile manufacturing, and the ability to lead teams through complex problem-solving and process optimisation.

QMS

Serve as the Production team technical lead for Quality Management System (QMS) activities.

Lead and manage:

Production Non-conformance investigations, root cause analysis, and CAPA implementation

Change Control coordination and technical assessment

Batch record creation and review, ensuring GMP compliance

SCAR (Supplier Corrective Action Request) support investigations and follow-up

Verification of Effectiveness (VoE) for implemented actions

Ensure all QMS documentation is audit-ready and aligned with regulatory expectations.

Act as SME for QMS and technical operations during regulatory inspections and internal audits.

Production & Technical Support

Provide hands-on technical support to sterile IV bag manufacturing operations.

Maintain a strong presence on the production floor to support resolution of process issues, provide guidance during critical operations, and ensure adherence to validated procedures.

Support production teams with technical troubleshooting, data analysis, and escalation of risks or non-conformances.

Ensure alignment between production activities, documentation systems, and QMS requirements.

Support scheduling, readiness reviews, and controlled documentation workflows

Operational Excellence (OPEX) & Continuous Improvement

Lead continuous improvement initiatives within Operations to enhance productivity, quality, and efficiency.

Collaborate cross-functionally to identify and implement OPEX projects using Lean, Six Sigma, or similar frameworks.

Develop, monitor, and report on key performance indicators (KPIs) for technical and manufacturing performance.

Foster a culture of continuous learning, ownership, and technical excellence.

Develop, and lead a high-performing team of technical experts.

Provide coaching, mentoring, and performance management to support team development.

Promote cross-functional knowledge-sharing and technical skill development across the department.

Bachelor’s degree in chemistry, Pharmacy, Chemical Engineering, Biotechnology, or related life sciences field.

8+ years of experience working in the pharmaceutical or medical device regulated industries.

Proven track record of managing QMS activities and investigations in a GMP-regulated setting.

Strong leadership and stakeholder management skills, with the ability to work effectively across departments.

Excellent understanding of regulatory requirements (FDA, EMA, etc.) and industry best practices in sterile manufacturing.

Experience in leading continuous improvement initiatives or OPEX frameworks (e.g., Lean, Six Sigma).

Master’s degree in a scientific or business discipline.

Experience with IV bag manufacturing, terminal sterilisation, or form-fill-seal technologies.

Familiarity with digital quality systems (MES, LIMS, Track Wise, Windchill etc.).

Prior involvement in tech transfers, scale-up activities, or remediation efforts