Manufacturing Support Engineer (BDS) TPM6099

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

Summary:

Our client, a leading biopharmaceutical company in West Dublin, is seeking a Manufacturing Support Engineer (BDS) for NPI supporting upstream and downstream manufacturing operations. The successful candidate will lead new product and technology introductions, resolve manufacturing issues and deliver process and equipment improvements in a safe, efficient and GMP-compliant manner.

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 compliance with GMP, regulatory and environmental health and safety requirements.
• Support equipment design, commissioning, qualification and validation, incorporating end-user requirements.
• Develop and improve procedures, work instructions and electronic or paper 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.

Qualifications & Experience:

• Bachelor’s degree in Science, Engineering, Biotechnology, Chemical Engineering or a related discipline.
• Minimum of three years’ experience in Manufacturing Operations, Technical Support, Process Engineering or Equipment Engineering within a biopharmaceutical or highly regulated industry.
• Knowledge of biological manufacturing and GMP environments, including media or buffer preparation, sterile filtration, and upstream or downstream processing.
• Experience supporting new product introductions, technology transfers, process validation and capacity expansion projects.
• Experience with manufacturing investigations, deviations, change controls, CAPAs and process or task-based risk assessments.