The Project Engineer will be required to lead, manage and control all engineering related activities on the relevant Work Package to deliver on requirements, budget and schedule in a safe and compliant manner. They will act as the key contact for the package and collaborate with the AZ client, AZGE SME and other AZ stakeholders fully define all necessary aspects of the delivery. This includes to define, manage and drive the delivery schedule for the work package to meet the overall project plan, from supplier selection to operational qualified state.
Project Engineer will secure and schedule capable resources to support relevant studies (FMEA, RCA, HAZOPs) and is responsible for ensuring the work package meets all the stage-gates associated with delivery.
They will have knowledge and experience of Project Engineering/management of GMP equipment package delivery in the pharmaceutical sector with an understanding of aseptic manufacturing environments and have a knowledge across a broad range of Engineering disciplines.
This role will be site-based at AZ’s new manufacturing site in Tuas, Singapore. Although, some overseas travel may be required therefore flexibility to spend periods away from home location will be required.
Once the major capital project is completed the role will switch to operational project engineering, operating within the site engineering organisations (or equiv.) across a broad range of environments.
Key Accountabilities:
- Ensures compliance of self and others to internal and external regulations.
- Promotes a positive Health and Safety culture on-site, leading by example to create a 100% injury-free environment.
- Management of supplier’s technical and commercial issues including escalation to AZ management.
- Follows AZ’s financial policies, manages people resources to policy requirements and delivers budgets.
- Optimises performance outcomes of direct/indirect reports and ensures individuals understand the contribution they make.
- Set clear goals and objectives for team and make it clear how they contribute to the wider organisational success
- Ensure that projects are implemented in line with identified AstraZeneca policies, procedures, and standards to achieve agreed scope and cost.
- Management of co-ordination of FAT, SAT, Qualification execution and support.
- To collaborate with colleagues in the project team to ensure all interfaces with other parts of the project are understood and accountabilities agreed to enable integrated activities to be successfully delivered.
- Responsible for setting the culture for right first time and quality to ensure work package meets all SHE, GMP & GEP compliance standards for use in a sterile facility.
- To identify risks such as commercial, design, schedule and make assessment of such risk and mitigate its impact on the work package, escalating as appropriate issues to the Process Equipment manager.
- Co-ordinate activities with Construction, Installation teams and Equipment Supplier during install of equipment into new facility.
- Monitor, control, and produce regular reports regarding package progress, risks and opportunities.
- Identification of potential changes in the scope of work and ensure that appropriate change requests are current, adequate, and communicated to the project team.
- Drives application of problem-solving tools to investigate problems and solve root cause. Leads complex investigations when required.
- Review of the following Quality Management System related documents:
o Change Management
o Deviation Management
o Capa Management
o SOPs
o Qualification and validations
o GxP documents according to internal procedures
- Ensure the quality risk management is embedded into decision making
- Ensure the issue escalation either through deviation tracking or internal procedures
- All engineering activities are executed in adherence to AZ Quality Management System
Requirements:
- Degree in an Engineering discipline with 10-15 years of experience with LTO responsibilities.
- Broad project management and pharmaceutical operational experience – Capital Projects – both manufacturing, supporting and commercial assets; deep operational maintenance experience (SAP/ERP knowledge) and be able to operate as SME for these areas
- Breadth of practical experience to support deliver of pharmaceutical project scope
- Self-motivated and able to act on their initiative, be highly organised with proven time-management and prioritisation skills.
- Significant & relevant delivery experience of asset & process improvement practices within a highly regulated environment.
- Resource and capital/operational cost leadership experience
- Strong problem solving and analytical skills, be a good communicator (written and verbal), have excellent people skills and the ability to quickly build rapport with others.
- Strong collaborator with ability to create and maintain effective working relationships and willing to challenge behaviours and actions, all within a globally based team.
- Strong customer mind set with good engagement skills.
- Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change.
- Experience of owning assets through whole life cycle – install, C&Q, operate and disposal.
