Bioprocess Associate

Morgan McKinley; Leinster; Presencial; EUR 52.000 - 68.000; Jornada completa

Descripción de la vacante

Morgan McKinley is seeking an Upstream Bioprocess Associate for a leading biopharmaceutical manufacturing organisation in Ireland. The role supports day-to-day manufacturing in a large-scale facility, including commissioning, qualification, and validation of process equipment and systems in a 24/7 shift environment.

Reporting to the Shift Lead, you will collaborate with Manufacturing Operations, Engineering, CQV and QA to ensure GMP compliance, execute processes to approved procedures, and

Formación

• Minimum Level 6 qualification in Engineering or Science.
• At least three years in large-scale biopharma manufacturing.
• Experience in regulated manufacturing (cGMP).
• Familiarity with MES and data acquisition technologies.

Responsabilidades

• Execute commercial-scale manufacturing processes per procedures and quality standards.
• Develop, review, and update SOPs and manufacturing docs.
• Operate and monitor production equipment in the designated area.
• Ensure GMP compliance and regulatory requirements.
• Support investigations, troubleshooting, and Lean-driven improvements.
• Collaborate with CQV, automation, and validation teams to support facilities.

Conocimientos

Process automation knowledge

cGMP experience

Analytical skills

Team collaboration

Strong communication

Educación

Level 6 qualification in Engineering/Science

Herramientas

MES (Manufacturing Execution Systems)

Descripción del empleo

Role Overview

A leading biopharmaceutical manufacturing organisation is seeking an Upstream Bioprocess Associate to join its Manufacturing Operations team on a contingent basis.

Reporting to the Shift Lead, the successful candidate will support day-to-day manufacturing activities within a large-scale biopharmaceutical facility, alongside commissioning, qualification, and validation activities for process equipment and systems.

This position operates within a continuous manufacturing environment and requires participation in a 24/7 shift rota.

Key Responsibilities

• Execute commercial-scale manufacturing processes in accordance with approved procedures, work instructions, and established quality standards.
• Develop, review, and update standard operating procedures and other manufacturing documentation.
• Operate and monitor production equipment within the designated manufacturing area.
• Ensure compliance with Good Manufacturing Practice (GMP), standard operating procedures, and applicable regulatory requirements.
• Participate in process investigations, troubleshooting, and optimisation activities using scientific, engineering, and Lean methodologies.
• Utilise process control, manufacturing execution, data historian, and other relevant business systems to support manufacturing operations.
• Assist with the review of batch records, manufacturing reports, and process exceptions in collaboration with Quality Assurance, contributing to investigations and audit-related activities where required.
• Collaborate with Manufacturing Operations, Engineering, Commissioning, Qualification and Validation (CQV), Automation, and Computer Systems Validation teams to support facility implementation, equipment qualification, process validation, and operational readiness.
• Contribute to a culture of continuous improvement and operational excellence by identifying and implementing improvements to processes, equipment performance, and workplace safety.
• Promote a safe working environment while maintaining high standards of quality, compliance, and operational performance.

Candidate Requirements

The ideal candidate will demonstrate the following:

• A minimum Level 6 qualification in Engineering, Science, or a related technical discipline. Equivalent relevant industry experience may also be considered.
• At least three years of experience working within a large-scale biopharmaceutical manufacturing environment.
• Experience working in a regulated manufacturing setting, ideally within a current Good Manufacturing Practice (cGMP) environment or a comparable controlled cleanroom industry.
• Familiarity with process automation, manufacturing execution systems (MES), and associated process monitoring and data acquisition technologies.
• Strong problem-solving and analytical skills, with the ability to investigate issues and contribute to effective solutions.
• The ability to work independently while collaborating effectively within multidisciplinary teams.
• Strong communication and organisational skills, with the ability to manage priorities and meet scheduled deadlines in a fast-paced environment.
• A proactive approach to continuous improvement, operational excellence, and maintaining a high standard of quality and safety.

Working Arrangements

Due to the nature of the manufacturing operation, this role requires flexibility to work shifts within a 24/7 production environment.