CSL Seqirus
Liverpool, Lancashire
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 benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL . 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 Inclusion and Belonging CSL . Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
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 benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL . 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 Inclusion and Belonging CSL . Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
CSL Seqirus
Liverpool, Lancashire
This role will provide Supervisory support for the Facilities Lead of Seqirus Vaccines Ltd. To ensure delivery of effective support services so the business remains competitive and lean to deliver Seasonal and Global Pandemic Influenza Vaccines across the globe. The Support services across the Liverpool Sites cover, but not limited to, Facilities Maintenance, Mechanical and Electrical, Compliance Management, Regulatory Audits, Standard Operating Procedures, Corrective Action plans and Deviations, EHS Compliance , Sub contractor Management and Permitting through Safe systems of work , involving Life safety systems, Water Hygiene Management, providing small works delivery program and Lifecycle Capital Project program using the Seqirus project management systems. These support services also extend to Logistics, Cleaning Porterage, Catering and Hospitality, Utilities Management. This will be carried out whilst utilising Performance metrics for all FM Providers. Under general supervision, supports facilities maintenance, modification and expansion projects • Supervises employees or outside contractors who construct, maintain, and repair utilities systems, buildings, and equipment • Plans and manages equipment and machinery maintenance, and facilities modification and building projects • Coordinates day-to-day activities to ensure operations run according to production specifications • Collects and monitors data to ensure accurate response to system problems; elevates cGMP related issues to management and Quality Assurance • Reviews and revises standard operating procedures (SOPs), specifications, drawings, etc. • Ensures operations comply with health and safety standards, local zoning laws and GMP regulations • Oversee Facilities Safe systems of work such as Access to work, Permit to work, Hot works • EHS Compliance management , Legionella Management, Fire Safety, Lifting operations, Emergency Lighting , COSHH • Strong Commercial /Budgetary Knowledge • Demonstrate working knowledge on a large Facilities Management Account in both Hard and Soft Services Education ONC/HNC in Mechanical or Electrical Engineering - Essential , Bachelor degree in Mechanical, or Electrical engineering - Desirable 3-5 years' experience related to Facilities Management /maintenance - Essential IOSH/NEBOSH Certificate Managing safely, Essential Competencies • Knowledge of safety and environmental regulations • Strong communication skills with customers, design teams, contractors, and management • Action oriented skills; ability to work in a fast paced environment • Good problem solving, technical learning, time management and prioritizing skills • Functional knowledge of cGMP sand manufacturing operations in FDA regulated facility 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 benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL . 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 Inclusion and Belonging CSL . Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
This role will provide Supervisory support for the Facilities Lead of Seqirus Vaccines Ltd. To ensure delivery of effective support services so the business remains competitive and lean to deliver Seasonal and Global Pandemic Influenza Vaccines across the globe. The Support services across the Liverpool Sites cover, but not limited to, Facilities Maintenance, Mechanical and Electrical, Compliance Management, Regulatory Audits, Standard Operating Procedures, Corrective Action plans and Deviations, EHS Compliance , Sub contractor Management and Permitting through Safe systems of work , involving Life safety systems, Water Hygiene Management, providing small works delivery program and Lifecycle Capital Project program using the Seqirus project management systems. These support services also extend to Logistics, Cleaning Porterage, Catering and Hospitality, Utilities Management. This will be carried out whilst utilising Performance metrics for all FM Providers. Under general supervision, supports facilities maintenance, modification and expansion projects • Supervises employees or outside contractors who construct, maintain, and repair utilities systems, buildings, and equipment • Plans and manages equipment and machinery maintenance, and facilities modification and building projects • Coordinates day-to-day activities to ensure operations run according to production specifications • Collects and monitors data to ensure accurate response to system problems; elevates cGMP related issues to management and Quality Assurance • Reviews and revises standard operating procedures (SOPs), specifications, drawings, etc. • Ensures operations comply with health and safety standards, local zoning laws and GMP regulations • Oversee Facilities Safe systems of work such as Access to work, Permit to work, Hot works • EHS Compliance management , Legionella Management, Fire Safety, Lifting operations, Emergency Lighting , COSHH • Strong Commercial /Budgetary Knowledge • Demonstrate working knowledge on a large Facilities Management Account in both Hard and Soft Services Education ONC/HNC in Mechanical or Electrical Engineering - Essential , Bachelor degree in Mechanical, or Electrical engineering - Desirable 3-5 years' experience related to Facilities Management /maintenance - Essential IOSH/NEBOSH Certificate Managing safely, Essential Competencies • Knowledge of safety and environmental regulations • Strong communication skills with customers, design teams, contractors, and management • Action oriented skills; ability to work in a fast paced environment • Good problem solving, technical learning, time management and prioritizing skills • Functional knowledge of cGMP sand manufacturing operations in FDA regulated facility 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 benefits you can participate in when you join CSL Seqirus. About CSL Seqirus CSL Seqirus is part of CSL . 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 Inclusion and Belonging CSL . Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus