Process Engineer, New Product Introduction (Temporary) - Ireland
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Our company are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
- Reporting to the New Product Introduction Associate Director, the primary role of the NPI Process Engineer is to support Manufacturing areas in product launch activities, and to lead and implement initiatives that add value to Operations.
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
- Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems
- Support and partner closely with peer team leads, Biotechnicians, and other colleagues to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
- Own, investigate, write and approve associated deviations as well as support & coaching Biotechnicians in these functions – ensure adoption of ‘zero late’ mentality in meeting timelines. Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviours
- Bachelor Degree in a Science or Engineering related field or equivalent experience is preferred.
- Demonstrable experience Root Cause Analysis tools and Change Control systems
- In depth understanding of Process Engineering and technologies pertinent to Upstream and Downstream Operations including Cell Culture, Chromatography, Filtration, Media Prep, Buffer Prep, is desirable
- Knowledge of the DeltaV process control platform is desirable
- Knowledge of FDA and EU regulations is desirable
- Work closely with Process Development, Manufacturing Science Group, Quality Operations, Facility Services and Manufacturing personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
- This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.