Entity: CSL Seqirus

Job Category: Engineering

Job Family: Process Engineering

Job Type: Full Time

Location: Liverpool, Merseyside, United Kingdom

Employer Reference: R-272434

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
• Lead Process Safety initiatives across supported areas and wider site, championing improvements and knowledge sharing
• 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/Process Engineering is expected. The candidate will ideally be a Chartered Engineer and fully conversant with application routes and requirements.

Experience Requirements

7+ years’ experience, preferably within Biotech/pharmaceutical Manufacturing environments with a specific background in cGMP.