NPI Manufacturing Support Engineer - Biopharma GMP

Tandem Project Management Limited; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Tandem Project Management Limited in West Dublin seeks a Manufacturing Support Engineer (BDS) to lead NPI, support upstream and downstream manufacturing operations, and drive process and equipment improvements in a GMP-compliant environment.

You will provide technical leadership across operations, support tech transfers, validation campaigns, and CAPA activities, while collaborating cross-functionally to deliver safe, efficient manufacturing.

Qualifications

• Bachelor's degree in a related field (Science/Engineering).
• Minimum 3 years in Manufacturing Operations, Technical/Process or Equipment Engineering in a biopharma or regulated setting.
• Knowledge of GMP environments including media/buffer prep, sterile processing, upstream/downstream.
• Experience with NPI, technology transfers, PPQ, validation, and capacity expansion.

Responsibilities

• Provide technical leadership across upstream and downstream operations; troubleshoot processes and equipment.
• Lead and support new product introductions and technology transfers; participate in PPQ and validation activities.
• Coordinate cross-functional projects on process improvement, capital investment, capacity expansion, new materials or equipment.
• Author/review protocols, reports, SOPs, batch records, risk assessments, change controls and CAPAs.
• Lead investigations and complete process, chemical, and task-based risk assessments.
• Ensure GMP, regulatory and environmental health and safety compliance.
• Support equipment design, commissioning, qualification and validation; incorporate end-user requirements.
• Develop and improve procedures, work instructions, and batch records (electronic/paper).
• Implement process optimization and error-proofing to improve safety, quality, throughput, and cost.

Skills

Manufacturing operations

Process engineering

CAPA management

Root cause analysis

GMP compliance

Technical leadership

Education

Bachelor's degree in Science/Engineering/Biotechnology/Chemical Engineering

Tools

QA/Change control systems

Validation and qualification

Job description

Tandem Project Management Limited in West Dublin seeks a Manufacturing Support Engineer (BDS) to lead NPI, support upstream and downstream manufacturing operations, and drive process and equipment improvements in a GMP-compliant environment.

You will provide technical leadership across operations, support tech transfers, validation campaigns, and CAPA activities, while collaborating cross-functionally to deliver safe, efficient manufacturing.