Biopharma Manufacturing Support Engineer for NPI

Tandem Project Management Ltd.; Dublin; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. is assisting a biopharmaceutical client in West Dublin to recruit a Manufacturing Support Engineer (BDS) for NPI.

The role leads new product introductions, solves manufacturing issues and drives process and equipment improvements in a GMP setting. The successful candidate will coordinate cross-functional projects, author critical documents and ensure regulatory compliance across upstream and downstream operations.

Qualifications

• Bachelor’s degree in Science, Engineering, biotech or related field.
• At least 3 years in biopharma manufacturing or regulated industry.
• Experience with GMP environments and upstream/downstream processing.
• Experience with new product introductions and technology transfers.
• Familiarity with CAPAs, change controls and risk assessments.

Responsibilities

• Provide technical leadership across upstream and downstream operations, troubleshooting process, equipment, automation, quality and operational issues.
• Lead and support new product introductions, technology transfers, PPQ campaigns, validation activities and commercial manufacturing.
• Coordinate cross-functional projects involving process improvement, capital investment, capacity expansion and new materials or equipment.
• Author, review and approve protocols, reports, SOPs, batch records, risk assessments, change controls and CAPAs.
• Lead manufacturing investigations and complete process, chemical, task-based and operational risk assessments.
• Ensure GMP, regulatory and environmental health & safety compliance.
• Support equipment design, commissioning, qualification and validation, incorporating end-user requirements.
• Develop and improve procedures, work instructions and batch records.
• Implement process optimisation and error-proofing initiatives to improve safety, quality, throughput, reliability, cost and Right-First-Time performance.
• Collaborate across functions to support project execution, training, knowledge transfer, audits and regulatory inspections.

Skills

Technical leadership

GMP knowledge

Process engineering

Cross-functional collaboration

Education

Bachelor’s degree in Science/Engineering

Job description

Tandem Project Management Ltd. is assisting a biopharmaceutical client in West Dublin to recruit a Manufacturing Support Engineer (BDS) for NPI.

The role leads new product introductions, solves manufacturing issues and drives process and equipment improvements in a GMP setting. The successful candidate will coordinate cross-functional projects, author critical documents and ensure regulatory compliance across upstream and downstream operations.