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Bioprocess Associate
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- Engineering
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- Communication skills
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Bioprocess Associate

WuXi Biologics -
Dundalk, County Louth

Apply Now

Job details

3 hours ago

Qualifications

Buffer (application)
Engineering
Manufacturing
Communication skills

Full job description

As a Bioprocessing Associate you will work 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.

To be considered for this role, it is essential you must possess one of the following profiles:

Proven Experience:

Minimum one year experience technical background and working experience from an industrial current Good Manufacturing Practices manufacturing, Contract Development and Manufacturing Organisation, or regulated pharmaceutical facility, with hands-on exposure to:

Upstream or Downstream Processing Operations
Biopharmaceutical Engineering or Pharmaceutical Biotechnology
Industrial manufacturing workflows and equipment scale-up

Relevant Education & Training:

A minimum of a Certificate, Diploma, or Degree in Science, Engineering Science, or a related field. This includes specific qualifications or specialized programs such as:

Pharmaceutical or Biopharmaceutical Degrees
National Institute for Bioprocessing Research and Training Certifications
Pharmaceutical Biotechnology / Biopharmaceutical Engineering
Upstream or Downstream Processing Operations

Essential Duties and Responsibilities

Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
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 optimisations 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 through the use of 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 ensuring full compliance at all times.
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 also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

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.

Experience

A minimum of one 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

Thorough knowledge of current Good Manufacturing Practices (GMP)
Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs

Qualifications

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

Behavioural Competencies
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

Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via [email protected]

WuXi Biologics is an equal opportunities employer.

Apply Now

Refine Your Search

jobs in dunleer, lh

Bioprocess Associate

Transport Administrator

Teacher of Maths & Another Subject

Bookkeeper/Office Administrator

The Member Relations and Events Manager

School Age Educator

Warehouse Operatives

QC BioAssay/Biochemical Assay Senior Scientist

Kitchen Hand/prep

Process Operator, Rendering (Shift Work)

General Operator, Biofuels

Office Administrator

Chef de Partie

Yard Manager

Quality Assurance

Solar Technical Support Advisor

Mobile Library Driver/Assistant

Trainee Pest Control technician

HR Generalist

Chef De Partie

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