Job description:
As Manufacturing Process Automation Associate Engineer, you will support the activities of the Manufacturing team with responsibility for providing automation and process support to the ongoing requirements for solution make up process in Manufacturing 6 and 7. This position requires a candidate who is/willing to be a multiskilled (Automation, Process, Equipment) expert in Biopharmaceutical Manufacturing.
Organization Description:WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Department Description: As Process Automation Associate Engineer, 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 report to the Technical Support Team Lead (or Manufacturing area AD)
Your Responsibilities:
- Interface with the project teams to ensure that manufacturing automation requirements are met, design the procedure flow chart and recipe for manufacturing project.
- Provide technical knowledge in establishing the commercial process and routine manufacturing automatic operations by serving as a commercial manufacturing automation, process and equipment subject matter expert (SME).
- Implement project related process CAPA’s and performance improvements, provide automation technical support and troubleshooting as required.
- As automation-relating deviation owner or investigator for manufacturing, if necessary, ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA's are identified and implemented.
- Lead Change Control write up and close out (project related) within manufacturing automation area.
- Ensure equipment for project use is designed and tested to meet the requirements of the process especially on automation, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state.
- Identify equipment automatic improvement projects on Energy/Time/Material/Cost saving.
- Support AIS team to do root cause analysis, incident investigations and troubleshooting issues related to electrical, instrumentation and equipment control systems.
- Review improvements, development of detailed specification, engineering documents, and standard operating procedures drafted by AIS team.
- Perform all duties in accordance with cGMP requirements, SOP's and controlled documents. Perform additional duties at the request of the direct manager.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Technology 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.
Your Profile: The ideal candidate for this position, will have the following:
Education:
- Third level qualification in a Science or Engineering related subject is preferable.
- Bachelor or Postgraduate’s in electrical engineering, Chemical Engineering, Biotech Engineering, or related life science engineering.
Knowledge/Experience:
Required:
- Minimum of 3 years’ experience in a large-scale in a Biopharmaceutical/pharmaceutical facility (with at least 2 years’ experience on DeltaV Batch Procedure Running, PLC experience is an additional advantage).
- Experience and knowledge of DeltaV platform, clearly understanding of each function of DeltaV and capable of doing automation batch processing (as per ISA S88/S95 Standards) configuration.
- Highly proficient in utilizing data tools (e.g. PI) and at least one programming language is an additional advantage.
- Experience in Drug Substance Operations with mammalian cell culture, protein purification, media and buffer preparation, CIP, SIP and production services.
- Must have a comprehensive understanding of process principles and the functional components of the equipment used in these process units.
- Direct experience in process control engineering with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
- Thorough knowledge of current Good Manufacturing Practices (cGMP).
- Deep understanding of fluid physics including dynamics and heat transfer is preferred (Knowledge on three fundamental conservation law of fluid properties: Momentum Balance, Energy Balance, Material Balance and how to control them).
- Knowledge on Biopharmaceutical Industrial Equipment Standards (e.g. ASME BPE, ISPE, PDA) is preferred.
Personal skills
Required:
- Excellent communication skills including computer literacy and ability to work independently and within a team.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to think critically and demonstrate troubleshooting and problem-solving skill.
- Self-starter and self-motivated; organized with good attention to detail.
- Comfortable working in a fast-paced environment and able to adjust workload based on changing priorities.
- Collaborative and inclusive approach to work and colleagues.
- Engage cross functionally in conjunction with a site-based team.
- 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 have the ability to 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 vision - 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. Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com
WuXi Biologics is an equal opportunities employer.