Job Description

This position is responsible for providing technical leadership within the process engineering department for equipment and process design for Seqirus Liverpool's products ensuring the engineering solutions meet cost, reliability, schedule, and performance integrity requirements. Additionally, this position is responsible for the planning and execution of all process engineering activities from preliminary design to routine manufacturing, coordinated with the project management team, including in-house/plant technical support
Responsibilities
To act as Lead Process Engineering SME for support of team members in the identification, investigation and provision of compliant solutions and innovations involving:

• 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)

Lead, as a subject matter expert:

• Working with the cross-function team, consolidate and refine requirements for process equipment and facilities.
• Responsible for preparing technical specifications throughout the procurement process to ensure that the user requirements are met. Negotiates cost delivery and technical/design feasibility with external suppliers.
• Responsible for managing delivery, issues and risks arising during the procurement, design, and construction phases of process equipment and facilities.
• Collaborate with project manager(s) to determine cost, platform and resource requirements in order to deliver projects on time and within budget.
• Participate in resolution of issues such as conflicting design requirements, unsuitability of standard material and difficult coordination requirements.
• Coordinate project activities with other operating or engineering units to facilitate participation of appropriate staff in project completion.
• Assign tasks to process engineering staff and supervise progress to ensure objectives are being met.

Monitor resource loading and prioritise activities to maximise the overall business contribution of the department, using agreed tools and metrics as required. 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

To advocate, encourage and enthusiastically adopt a culture of participation, knowledge sharing, involvement, and focus on anticipating and preventing potential problems. Maintain an external focus to ensure industry best practices are incorporated into Liverpool Operations and site technical standards. 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. Participate in professional organizations to maintain current knowledge of technical innovations.
Education Requirements
A recognised degree in Chemical or Mechanical Engineering is expected. The candidate must be a Chartered Engineer and fully conversant with application routes and requirements.
Experience Requirements
10+ years' experience within Biotech/pharmaceutical Manufacturing environments with a specific background in Biologics sterile/aseptic fill finish preferred
Please note this role is a 12 Month Fixed term Contract opportunity
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the you can participate in when you join CSL Seqirus.
About CSL Seqirus
is part of . As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
We want Seqirus to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more .
Do work that matters at CSL Seqirus!
Watch our 'On the Front Line' video to learn more about CSL Seqirus

Skills Required