Senior Bioprocess Engineer

DPS have a requirement for a Senior Bioprocess Engineer with a Dublin based Pharmaceutical client.

Key responsibilities of the role will include the use of process engineering systems and approaches for equipment design, specification and performance, generation of technical reports, process modelling, risk management and integration of process equipment systems. Ongoing optimiz704689.975403ation of process equipment and development of future breakthrough business solutions will be key focus areas. The role will involve working as part of a team of bio-process engineers who will be responsible for ownership and management of change of the electronic batch records, identifying equipment, recipe and process improvements and managing and controlling changes in these areas. The senior bio-process engineer will lead significant projects and will play a key role in the coaching and development of the Manufacturing technical team.

Additional Responsibilities: 

• Use a focused, technical, problem solving approach to meet and exceed on functional and site goals and objectives.
• Act as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, conducting and leading investigations
• Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance 
• Play a key role in developing process engineering related documents, technical SOPs, reviewing automation related functional design specifications and generating technical reports
• Be an owner of specific EBRs in the facility, making technical changes are required to meet the demands of the business or in response to any requirements for process changes that may occur. Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility
• Own the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.
• As a senior bioprocess engineer within the team take the lead on specific manufacturing projects that arise on the process, equipment or systems providing a structured lean approach to problem resolution
• Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on removing barriers to maintain a highly effective and productive self-directed team environment.
• As a key member of the start-up team on site play a key role in the commissioning and qualification activities on site, acting as a lead end user for systems as they transition across to the operations teams. Ensure consistency between recipe design and technical SOPs
• Stay abreast of industry innovations, looking at ongoing optimisations of the single use technology being employed on site.
• Act as a key SME for the introduction of new process equipment into the facility, and provide technical training or support for the operations-based manufacturing personnel as equipment is brought on line

Requirements:

• Bachelor’s degree in a technical discipline (Science or Engineering)
• At least 5-8 years’ experience in the biotechnology and/or pharmaceutical industry, with experience in automated systems a distinct advantage (PAS systems, MES systems)
• Acting as system owner and subject matter expert (SME) to support new equipment introduction & MES recipe build 
• Support Tech Transfer and site readiness activities
• Experience leading significant process or plant improvement projects
• Proven ability around working cross functionally, delivering technical solutions to manufacturing issues and identifying solutions. 
• Experience working in a self-managed work team, embracing an interdependent working culture that delivers results. 
• Strong operations support background ensuring value added contribution and oversight.
• Experience working in a GMP manufacturing environment

DPS is an Equal Opportunities Employer.

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