Technical Specialist

PE Global; Cork; On-site; EUR 60,000 - 95,000; Full time

Job summary

PE Global is recruiting a Material Science Technical Specialist for a Cork-based client on a 23-month contract. The role focuses on single-use technologies (bags, filters, tubing assemblies) and biopharmaceutical materials with strong emphasis on cGMP transfers.

The candidate will assess raw materials, lead process improvements, and utilize QMS tools (Veeva, TrackWise) to implement changes and support commercial and clinical operations. Travel to conferences and training may be required.

Qualifications

• 3–5 years experience with single-use technologies in biopharma.
• BS/MS in Life Sciences with related experience.
• Knowledge of USP and material standards.
• Experience transferring processes to cGMP environments.
• Ability to manage multiple projects and communicate status clearly.

Responsibilities

• Lead harmonization and optimization initiatives for single-use tech.
• Develop raw material platforms and supplier relationships.
• Assess supplier changes and approve raw materials.
• Support tech transfer to manufacturing and commercial operations.
• Manage CAPAs and change controls in QMS.
• Generate project plans and reports.
• Educate on raw materials and governing standards.

Skills

Material Science

Biopharmaceutical Manufacturing

Process Development

Project Management

Communication Skills

Education

BS in Life Sciences

MS in Life Sciences

Tools

Veeva

TrackWise

Microsoft Office

Job description

PE Global are recruiting for an Material Science Technical Specialist on behalf of our client based in Cork:

23 month contract

Emerging role for someone with 3-5 years experience with single-use technologies

This position requires the utilization of expertise relevant to biopharmaceutical materials and processes with an emphasis on single use technologies (bags, filters, tubing assemblies, drug product materials). Technical expertise in biopharmaceutical manufacturing materials is required to provide support to Commercial and Clinical manufacturing operations. This position requires a detailed knowledge and understanding of product-contacting materials, technologies, applications, and suppliers. This position can also require knowledge of industry standards that govern raw materials (USP, etc.). Candidate will assess and approve raw materials for use. Candidate will lead, develop, and implement process improvement initiatives via evaluation of current raw materials, practices, process history, equipment, and technologies.

He or she will support transfer of new processes from Process Development into a cGMP Manufacturing environment. He or she will utilize existing methods and Quality Management System tools (Veeva, TrackWise, etc.) to implement new raw materials or processes, or to make changes to existing raw materials or processes.

He or she should be detail oriented while also operating with a broad strategic perspective.

Periodic travel may be required to attend relevant professional conferences, workshops, or trainings, support technical transfer, and/or evaluate systems, processes, and technologies.

RESPONSIBILITIES

• Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives and/or projects with an emphasis on single use items and technologies
• Assist in the development of site/company standard raw material platforms and business practices
• Assess raw material supplier change notifications, complaints, etc.
• Evaluate and/or test the feasibility of new manufacturing raw materials
• Responsible for technical evaluation of proposed raw material changes to Manufacturing processes
• Support technology and process transfer to and from the Manufacturing areas or facilities to ensure developing processes align with established large-scale and/or Commercial Manufacturing raw materials and practices
• Manage raw material change requests, CAPAs, and Action Items via Veeva QMS
• Oversee project milestones, departmental goals, and carry out strategic initiatives
• Communicate progress and status of projects clearly and effectively
• Create projects, spreadsheets, and presentations via Microsoft Office programs
• Continued education on understanding of raw materials and their governing bodies

EXPERIENCE

• Experience in Material Science, Biopharmaceutical Manufacturing, Manufacturing Sciences and Technology, and/or Process Development
• Strong knowledge of and expertise of pharmaceutical single use raw materials (bags, filters, tubing assemblies, drug product materials, chemicals, media, resin)
• Established working relationship with raw material suppliers
• Basic understanding of biopharmaceutical processes and raw materials used to support manufacturing operations
• Strong technical understanding of general biopharmaceutical manufacturing processes and techniques (bioreactor operations, depth filtration, media/buffer preparation, etc.)
• Experienced in the transfer of processes and technology to cGMP and/or clinical operations
• Experienced in cGMP and with large-scale manufacturing equipment and practices
• Knowledge and understanding of regulatory agency guidelines, expectations, and best practices
• Knowledge of raw material standards (USP, BioPhorum, etc.)
• Proven project management, organizational, and communication skills
• Proven ability to independently manage work, actions, and expectations
• Proven ability to handle multiple tasks concurrently and be flexible and adaptable
• Proven ability to meet deadlines
• Strong knowledge of and experience using Microsoft Office programs (Project, Excel, PowerPoint)

EDUCATION

BS in Life Sciences with 3-5 years of relevant experience in Material Science, Biopharmaceutical Manufacturing, Manufacturing Sciences and Technology, and/or Process Development or MS with 2 years of relevant experience

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***