Manufacturing Support Engineer (BDS)

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

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

• Bachelors 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.
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