Bioprocess Associate (4716)

As an experienced 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 largescale Drug Substance.

Department Description

As Bioprocess Associate you will be joining an organisation 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 maintaining a safety orientated Culture cGMP compliant work environment always.
• Where necessary assist in Facility and Equipment startup and Validation activities.
• Provide input on equipment installation startup 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

• A Certificate Diploma Degree or equivalent qualification in Science Engineering or a related field is essential. This includes disciplines such as Biopharmaceutical Science Pharmaceutical Science or similar.

Knowledge/Experience

Required:

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

Technical Competencies

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

Required:

• 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 sitebased team.
• Autonomous and a selfstarter 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 fastpaced 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 dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!

Would you like to know more before you apply Please visit us at or contact us via

WuXi Biologics is an equal opportunities employer.