As Bioprocess Associate FTC 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 Bioprocess Associate FTC, 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 Manufacturing Shift Lead.
- This role is a fixed-term contract of 6 to 12 months, providing maternity cover.
Your Responsibilities:
- Assist in maintaining a safety-oriented Culture, cGMP compliant work environment always.
- Where necessary, assist in Facility and Equipment starts up and Validation activities.
- Provide input on equipment installation, start-up, operation, and troubleshooting to support the 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 optimizations of processes using scientific, engineering, and lean principles.
- Training and mentoring of colleagues in SOPs, process execution, and equipment operation.
- Write, review, and revise 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 the 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 the highest Quality & Compliance standards.
- Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
- Be flexible to take on additional tasks and responsibilities at the discretion of the MFG Shift Lead.
- Act as a role model for the Manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture.
Education:
Certificate, Diploma, Degree, or equivalent in Science, Engineering, or a related field is advantageous.
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.
- Thorough knowledge of current Good Manufacturing Practices (GMP).
- Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs.
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, challenge, and building a new future together. If you can thrive in a dynamic and fast-paced environment and are ready to be part of an exciting journey toward accomplishing our vision—where 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 to discover your true potential. Apply now!
WuXi Biologics is an Equal Opportunities Employer.
