Project Lead/Manager M2U
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Position is a leadership role as the Project Manager of Maintenance, Facilities & Utility Projects (M2U). Responsible for developing, evaluating, and implementing cost-effective equipment, facility and utility engineering solutions for a manufacturing facility in a fast-paced cGMP, biotechnology environment. This includes all phases of the project including conception, developing justification, presenting to management, preparation of capital impact analysis, budget management, project timeline creation and management, detailed design, creating specifications (Design/Functional/System) and vendor/contractor scopes-of-work, competitive bidding, placing purchase orders, contractor and consultant supervision, creating and executing change control documentation, performing factory and site acceptance tests (FATs/SATs), installation, commissioning, debugging, optimization, supporting Validation and training maintenance/plant personnel.
Expected to make suggestions on improvements based on supporting data, technical knowledge, engineering principles and current industry practices
Lead the planning and execution of plant and capital projects related to production and/or facility requirements, with oversight and responsibility of the capital portfolio for M2U projects
Assist with preparation and management of key engineering and supply contracts M2U.
Demonstrated ability to work with an engineering team and to work effectively in an engineering network.
Establishing, tracking, and managing project schedule/critical path activities, status reporting, and resource plan development to ensure projects are completed on time, on-schedule and within budget.
Undertake, direct, or assist others in the preparation and approval of Capital Expenditure Proposals relating to the project.
Ensure team members understand project objectives, specifications, deliverables, timelines, and tasks through ongoing clear, concise communication & motivation of project team members.
Identifying issues that may delay project deliverables and recommending appropriate risk mitigation strategies, contingencies, and actions to be taken.
Ensure that risk management methodologies and processes are followed in a project.
Undertake, direct, or assist others in the preparation of specifications, drawings and other documentation that comprise the technical requirements for inclusion in tenders and contracts.
Manage and co-ordinate Qualification activities with the Qualification group.
Undertake, direct, or assist others in the development of operational documents, maintenance manuals and training in the documents.
Ensure that projects are managed in a way that recognizes GMP and the need to actively manage the risk of non-compliance.
Participates in Regulatory Agency audits.
Collaborating with and providing ongoing project updates to senior management and functional leaders to ensure integration and achievement of project milestones.
Providing direct input into corporate strategic planning, development management processes, and project management from conception through development cycle.
Work closely with site Operations and Quality management to manage and prioritize the production schedule as it relates project deliverables and deadlines.
Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.
Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
Stay current with biopharmaceutical industry best practices and technologies
Completes any other duties/responsibilities assigned by senior management.
Bachelor's Degree in Mechanical, Electrical or Chemical Engineering strongly preferred. Five plus years of experience in the industrial field with extensive project management experience may be considered. Having PMP Certification will be significant plus.
Excellent knowledge of plant equipment maintenance and a basic understanding of related mechanical equipment is required
Must know how to effectively run projects, coordinate contractors, direct technicians, and field the activities.
A sound understanding of
- Quality management systems and procedures.
- Risk management methodology and processes.
- Contract management and administration.
Knowledge of Six Sigma / Lean principles a plus
Well-developed ability in working with others through a matrix management structure.
Advanced skills in MS-Project, MS-Excel, MS-Word, MS-PowerPoint, MS-Visio,
Power BI, and MS-Outlook.
Understanding of GMP and GLP principles.