Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
This is a technical role focussed on supporting the Liverpool Manufacturing strategy to meet the business goals. The role will be broadly split into two main areas:
1. Ongoing support of manufacturing operations
2. Definition and execution of plant modifications and engineering projects to meet strategic business performance targets (e.g. financial, supply chain, write-offs, cGMP & EHS)
- Act as Process Engineer in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects
1. Act as a technical Subject Matter Expert (SME) to assume responsibility for the performance of key plant unit operations with a focus on continuous improvement of:
- Process safety
- Regulatory compliance
- Cost of Goods
- Operational reliability (process and plant)
- Process yield
- Energy efficiency
2. Monitor plant performance and scope and deliver improvement projects using Six Sigma tools and Project Management methodologies including:
- Process Design
- Design Qualification, Design Review and HAZOP studies
- Process, equipment & component specification (plant, instrumentation, automation & consumables/disposables)
- Change control management
- Input into budget development and securing of Opex & Capex funding
- Automation approach including the Sequence of Operations and FDS definition
- Commissioning, validation and handover (FAT, SAT, FT/Commissioning, IQ, OQ, PQ, CV, CSV)
- Technical training of operational staff
3. Ensure that customer expectations are met for business KPIs and work priorities including:
- savings targets
- on time closure of deviations, CAPAs, change controls, MRFs and regulatory commitments
- project selection & portfolio management
4. Responsible for managing and supervising consultants/suppliers and contract staff carrying out project work, with particular emphasis on health & safety aspects of site work. Supervisory responsibilities will include use of Permit-to-Work and plant isolation procedures.
5. Uphold and contribute to the development of site engineering standards to comply with regulatory and pharmaceutical industry requirements. Ensure that appropriate standards of GMP, housekeeping, safety and discipline are maintained at all times both within the department and operational areas.
6. Responsible for end-to-end process change procedures, handling a wide range of types of project – from process control software modifications to minor capital projects or participation on larger capital projects.
Many of the process changes to be handled will be documented in the Quality Management system and as such, may be subject to regulatory scrutiny.
Bachelor’s degree in Chemical engineering or construction or equivalent preferred
Chartership or working towards Chartership status would be desirable
Analysis and project definition experience
Strong communication skills with customers, design teams, contractors, and management
Action oriented skills; agility to working in a fast paced environment
Good problem solving, technical learning, time management and prioritizing skills
Functional knowledge of cGMP’s and manufacturing operations in FDA regulated facility
Excellent interpersonal, communication and team working skills are required coupled with the ability to think independently and influence across the organisation.
Over time, the role holder should develop the technical authority to act as a process SME for specific process steps or departments and proactively influence project selection and prioritisation.
Key stakeholders typically include manufacturing users and maintenance engineers, but close working relationships are necessary with other support functions, most notably automation and validation teams.
The role holder must be open to alternative technical options and demonstrate to stakeholders that the best value solution has been put forward.
They must also become fully conversant with multiple complex change procedures to successfully deliver objectives in an efficient manner.
A creative approach to problem solving is required and an outward focus is important to ensure that new technologies, new suppliers and industry best practices are factored into change proposals.
A sound knowledge of environmental, health and safety legislation and a practical approach to safety issues is of fundamental importance to the job, to ensure that EHS matters are properly considered in the design and realisation of change proposals.
The role-holder must have a firm grasp of project management fundamentals.
Experience of inspection and packing operations is preferred
Worker Sub Type: