Bioprocess Associate

Role Title – Bioprocess AssociateRole Type – ContractLocation – Dublin 15We are currently recruiting for Bioprocess Associates for a Biopharmaceutical Manufacturer in Dublin 15. The Bioprocess Associate is responsible for all procedures and processes associated with the manufacture of Drug Substance at the manufacturing facility, at the highest standards of Safety, Quality and Compliance. They are also responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift. Role Functions• Support operations team to consistently deliver on specific Key Performance Indicators (KPIs).• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).• Maintain/ support a high standard of safety/ Good Manufacturing Practice (GMP) compliance at all times.• Work as part of a dedicated process team where flexibility and teamwork are a key requirement.• Adhere to Right First-Time principles.• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.• Take part in shift handovers and meetings, raising concerns or issues promptly and providing options for resolutions.• Get actively involved by participating in inspections, GEMBA’s and Go-See’s.• Utilize Lean Six Sigma Tools to support the initiative of continuous improvement (CI) projects to increase agility, flow, throughout and reduce cycle time and inventory.• Participate in internal audit programs and risk assessment compliance activity.• Promote EHS leadership behaviours and engages employees at all levels on EHS issues.• Promote an environment where everyone speaks up for our culture of safety and looks out for one another.Experience, Knowledge & Skills• Demonstrate successes in a team environment in either a project or work related activities.• Demonstrate troubleshooting competency.• Desire to learn and develop.• Ability to interact with multiple stakeholders across numerous departments.• Excellent communication skills.• Ability to manage multiple priorities and know when to escalate issues for resolution.• High degree of problem-solving ability and adherence to scheduled timelines.• A proven ability to lead cross functional teams and deliver on tight timelines.Technical:• Understanding of Drug Substance Manufacturing Operations.• Understanding of GMP requirements in a Biopharmaceutical Facility.• Excellent communication skills and the ability to work in a cross functional collaborative environment.• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.• Possess a detailed overview of the overall upstream/ downstream process, with expertise andknowledge of the manufacturing process.• Maintain a high level of expertise and working knowledge of the process equipment.• Can lead and deliver cross-functional Operational Excellence projects/ Initiatives.• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.Qualifications & Education• Minimum Level 7 qualification in a science or engineering discipline, or level 6 with a minimum of 1 - 3 years’ experience in a GMP Manufacturing environment.• Experience of Upstream/ Downstream Processing.• Experience in a highly regulated pharmaceutical manufacturing environment.• Proven record of accomplishments in a regulated industry.• Start-up experience in a large-scale commercial drug substance facility, or similar.This role is a site-based role.• This role will involve working shifts, on a 24/7 basis.