Associate Director, Process Architecture and Design
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!
Reporting into the Global Head of Engineering Standards, the Associate Director, Process Architecture and Design will be responsible for oversight of process and detailed architectural design deployment related to capital investments across the CSL US/EU/APAC network. The individual will be responsible for discipline specific engineering standards, and technical compliance with standards across capital project design phases.
This individual will influence; capital strategy and E2E delivery through site master planning development, translation into capital plans, supporting the Global Engineering knowledge based network, leading feasibility, simulations and 3D model development, and utilizing technical knowledge (both industry and internal best practices and standards).
The incumbent must demonstrate comprehensive knowledge of process and detailed architectural design fundamentals, technical core competency for discipline specific elements related to facilities and related equipment engineering processes and platforms, and cGMP compliance.
They will be responsible for regional and architectural design standards related to their discipline function.
As part of a global organization, the position requires approximately 20% travel. Peers will be located across CSL Behring US/EU/APAC sites.
The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.
This position reports to: Global Head of Engineering Standards
Reporting to this position: N/A
Internal Interaction: This position partners with site stakeholders and subject matter experts, Corporate Quality, R&D and the engineering community. They will work closely with Global Leadership and occasionally with Site Leadership.
External Interaction: Engineering/Design Services Partners, Industry Peers, Vendors
Main Responsibilities and Accountabilities:
Provide Architectural Design Leadership for engineering capital investments across the US/EU/APAC network
- Collaborate with Engineering and Design Lead to align on standards applicability related capital investments
- Partner with Engineering and Design Lead to assure requirements for compliance with applicable standards are communicated for capital investments
- Responsible for communicating standards’ requirements to Site Peers
- Analyze and develop technical solutions related to existing portfolio and emerging product facilities, consistent with industry best practices and emerging trends, meeting Regulatory requirements
- Responsible for architectural solutions for Plasma, Monoclonal Antibodies, and Fill & Finish manufacturing facilities
- Experience and capacity to plan and design cGMP manufacturing and lab facilities, demonstrating knowledge of operating facility requirements to define general arrangements, operational flows, adjacency schemes, environmental classifications, and interpretation and justification of regulatory requirements
- Strong working knowledge of local, state, and federal building codes and various industry standards
- Define, develop, and execute project deliverables as a Stakeholder facing leader, develop and maintain internal and external relationships
- Proficient utilization of common design tools across E2E capital delivery process; BIM which leverages Autodesk Revit, Recap and Navisworks software required
- Provide oversight of architectural design related to capital investments
- Engage site resources in design process, develop shared oversight plans where site support is enlisted
- Responsible for compliance of capital investments with design standards and standard design platform governance process
- Facilitate review and disposition of cGMP Audit findings and recommendations
- Represent Global Engineering throughout the matrix environment in the communication of capital investment execution requirements
Provide Global Engineering Leadership for Engineering Standards
- Responsible for Architectural Design Standards applicable across the US/EU/APAC network
- Collaborate with interdependent Global Engineering functions to align on standards
- Translate stakeholder preferences into design attributes, collaborate to align on best practices which form the basis for Design Standards
- Responsible for ensuring harmonization of Architectural Design Standards across the global network
- Partner with Peers to align on Quality, Safety, IT/Automation, Reliability and Sustainability requirements for design standards. Facilitate collaborative sessions to align on design standards attributes to meet requirements
- Maintain Architectural Design Standards throughout Life Cycle
- Document Lessons Learned and translate into standards’ refinement
- Evaluate innovation and emerging technologies for opportunities to realize efficiency and compliance improvements
- Provide training and ensure institutionalization across engineering community
- Establish and lead Architectural Community of Practice
Provide Global Engineering Oversight of external partners for capital investments
- Partner with Engineering and Design Lead to evaluate external resource requirements and ensure adequate engagement
- Provide oversight of external partners and ensure compliance with Engineering Standards
- Drive E2E design solutions linked to business objectives through the use of Interactive Planning Sessions
- Lead design reviews of deliverables prepared by external Partners, provide feedback and ensure disposition
- Perform and or provide oversight of Peer Reviews to ensure deliverables comply with requirements, standards and stakeholder expectations
- Support Global Sourcing in the technical reviews and engagement of equipment vendors, and execution of Agreements
- Responsible for feedback to Global Sourcing for management of strategic Agreements
Position Qualifications and Experience Requirements:
- Bachelor’s degree in architecture or engineering required, advanced education a plus, with at least 8 years of architectural in a biotech/pharmaceutical environment. Registered Architect or Professional Engineering Certification preferred.
- Minimum of 8 years’ experience in a biotech/pharmaceutical environment in roles with career progression the engineering space.
- Direct experience with performing process and detailed architectural design function, coordination, calculations, and deliverables in a cross-functional engineering environment
- Experience in master planning and feasibility assessments required to support Business Analysis
- Substantial experience with facility layouts including personnel, equipment, material and waste flows, transitional space design
- Experience with work space, manufacturing footprints and lab programming
- Significant experience with life safety egress design
- Prior experience with architectural finishes and details, operational features and implementation methods common for Life Sciences facilities
- Experience with construction of facilities, startup and debug, and related turnover to operations
- Direct experience with BIM design collaboration software capabilities and application
- Substantial experience with industry standards and best practices, cGMPs, and US/EU/APAC Regulations
- Experience with capital investments ranging in scale and complexity
- Experience with project design phases and the related level of architectural design detail required at each phase
- Excellent collaborative skills and an ability to prioritize effectively to deliver results within aggressive timelines, and with the ability to work independently and as part of a team
- Prior experience in the development, implementation and direct use of engineering standards and life cycle management of tools, processes and methodologies
- Demonstrated ability to deliver on commitments in a dynamic environment
- Excellent collaboration skills and ability to align people and resources towards organizational success
- Must demonstrate tactical thinking and the use of innovative approaches to achieve solutions
- Nimble and comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Must demonstrate maturity and judgment in reaching critical decisions
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Managerial Courage: Does not hold back anything that needs to be said; provides current, direct, complete, and ‘actionable’ positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation quickly and directly; is not afraid to take negative action when necessary.
- Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practice, trends and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
- Drive for Results/Execution: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
- Strategic Agility: Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
- Decision Quality: Makes good decision based upon a mixture analysis, wisdom experience, and judgment; most his /her solution and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Innovation Management: Is good at bringing the creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; has a sense about managing the creative process of others; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace.
- Developing Talent: Provides challenging and stretching tasks and assignments; holds frequent development discussions; is aware of each person’s career goals; constructs compelling development plans and executes them; pushes people to accept developmental moves; will take on those who need help and further development; cooperates with the developmental system in the organization; is a people builder.
- Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.
- Managing Vision and Purpose: Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision sharable by everyone; can inspire and motivate entire units or organizations.
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvement in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
- Organizing: Can marshal resources (people, funding, material, support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently.
- Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.
- Negotiation Skills : ability to work into a matrix organization and able to influence and persuade, without having a direct authority
- Communication: ability to dialogue and convey effective message through the organization at different levels and across cultural differences; unbiased.
- Financial Acumen: understand business needs and translates into plans and actions with a clear and measurable value proposition.
- Basic understanding of c-GMP’s and EHS&S requirements globally.
- Mature Understanding of Contracting models and its applicability worldwide.
- Ethical conduct: understanding of owning anticorruption practices.