Bioprocessing Associate

WuXi Biologics; Leinster; On-site; EUR 36,000 - 48,000; Full time

Job summary

WuXi Biologics Dundalk is seeking an Inoculation and Cell-Bank Bioprocess Associate to support production of commercial Drug Substance. You will work with Manufacturing teams, follow SOPs, and help maintain cGMP-compliant operations.

The role requires 0–3 years in biopharma manufacturing, knowledge of aseptic technique and GMP, and experience with bioprocessing equipment, SAP, and TrackWise. You will train colleagues and contribute to continuous improvement while upholding safety and quality.

Qualifications

• Certificate, Diploma, Degree or equivalent in Science, Engineering or related field.
• 0–3 years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing.
• Experience in a greenfield context is an advantage.
• Strong knowledge of GMP and aseptic techniques.

Responsibilities

• Assist daily operations in the Inoculation and cell bank team.
• Maintain a safety-oriented, cGMP-compliant work environment.
• Support start-up and validation activities for facilities and equipment.
• Provide input on equipment installation, start-up, operation and troubleshooting.
• Contribute to achieving production output targets and quality on schedule.
• Record and follow SOPs, batch records, logbooks, and training.
• Identify improvement opportunities using Lean/Six Sigma tools.
• Notify supervisors of deviations and participate in investigations.
• Train and mentor colleagues in SOPs and equipment operation.
• Maintain high safety and regulatory standards.

Skills

Bioprocess knowledge

GMP knowledge

Aseptic technique

Problem solving

Education

Science/Engineering degree or equivalent

Tools

SAP

TrackWise

Process automation systems

Bioreactors

Centrifuges

Autoclaves

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

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 Competencies

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.

WuXi Biologics is an equal opportunities employer.