Bioprocessing Associate

WuXi Biologics; Leinster; On-site; EUR 32,000 - 52,000; Full time

Job summary

WuXi Biologics invites applications for an Inoculation and Cell-Bank Bioprocess Associate at our Dundalk facility. You will work closely with Manufacturing teams to support production of commercial Drug Substance, following GMP, SOPs, and batch records.

The role requires 0–3 years in biopharmaceutical manufacturing, knowledge of aseptic technique, and a collaborative, proactive approach to continuous improvement within a fast-paced environment.

Qualifications

• 0–3 years’ experience in biopharmaceutical cGMP manufacturing.
• Knowledge of aseptic technique and GMP.
• Familiar with bioprocessing documentation (batch records, SOP).
• Experience with process automation is a plus.

Responsibilities

• Support daily operations within the inoculation and cell bank team.
• Maintain a safety‑oriented, cGMP compliant work environment.
• Assist in facility start-up, validation, and equipment start-up.
• Contribute to investigations and optimization using Lean principles.
• Write and revise SOPs, batch records, logbooks, and training docs.
• Support continuous improvement using Lean/Six Sigma tools.
• Adhere to safety policies and ensure quality and compliance.
• Mentor colleagues and train on SOPs and equipment operation.

Skills

cGMP knowledge

Aseptic technique

Bioprocessing basics

Problem solving

Communication skills

Education

Science/Engineering degree

Tools

SAP

TrackWise

Job description

As Inoc. and Cell-Bank Bioprocess Associate you will be responsible for working with the wider Manufacturing teams to support the production of biological products at the Dundalk facility. This role will be responsible for procedures and processes associated with the manufacture of commercial large-scale Drug Substance.

Department Description

As Inoc. and Cell-Bank Bioprocess Associate, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will be reporting to the Shift Lead.

Your Responsibilities:

• In this role, you will assist in daily operations within the Inoculation and cell bank team.
• Maintaining a safety orientated Culture, cGMP compliant work environment always.
• Daily operations within the Inoculation and cell bank.
• Where necessary assist in Facility and Equipment start-up and Validation activities.
• Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
• Assist as a member of the Production team, towards the delivery of production output targets and quality levels on schedule.
• Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures and Manufacturing Batch Records.
• Perform initial troubleshooting of issues identified during routine operations.
• Take part in investigations and optimization of processes using scientific, engineering, and lean principles.
• Training and mentoring of colleagues in SOPs, process execution and equipment operation.
• Write, review and revision of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions
• Seek opportunities for Continuous Improvement using Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
• Immediately notify the Shift Lead or Senior Team Member of any deviation from SOPs and/or deviations in the standard production process
• Perform housekeeping duties as assigned to maintain facility at a high standard.
• Complete all training in a timely manner. Maintain assigned training always ensuring full compliance.
• Adhere fully to all safety policies, procedures, and regulations.
• Ensure highest Quality & Compliance standards.
• Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Shift Lead.
• Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position, will have the following:

Education

Certificate, Diploma, Degree or equivalent in Science, Engineering or related field is essential.

Knowledge/Experience

• 0-3 years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing
• Experienced in the Manufacturing function in a ‘greenfield’ context of similar size and scale is an advantage.
• Knowledge of Aseptic Technique.
• Thorough knowledge of current Good Manufacturing Practices (GMP)
• Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOP.

Technical knowledge of bioprocessing/biotechnology and Upstream and /or Downstream biologics processes.

• Technical knowledge of bioprocessing/biotechnology and Upstream and /or Downstream biologics processes.
• Ability to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system.
• Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems.

Personal skills

• Excellent communication, interpersonal and presentation skills.
• Collaborative and inclusive approach to work and your colleagues.
• Excellent problem solving and troubleshooting skills.
• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
• Engage cross functionally in conjunction with a site-based team.
• Autonomous and a self-starter who will use their initiative to drive actions forward.
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you can thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

WuXi Biologics is an equal opportunities employer.