Are you the ‘creative builder of the future’ we are looking for? Your high interest in how the world will look like years from now and your strong technical leadership will help you to make robust decisions for the present that provides innovative solutions for our business needs.
MAKE Asset Management (MAM) is committed to deliver reliable, competitive and innovative Asset Management across the Janssen MAKE network. MAM provides agile, future proofed, data driven services and solutions to enable MTO platforms to deliver to our customers. MAM establishes effective internal and external partnerships and fosters an empowered environment that fuels diversity, talent and expertise.
The Engineering Project Delivery Engineer is a member of the SM API MAM Cluster Engineering Team. In this position you are responsible for providing innovative engineering solutions to problems and opportunities, advanced engineering design for complex production and processing equipment, construction of manufacturing facilities, systems and equipment, transfer of knowledge to the user and maintenance and for providing ongoing operational engineering and technical support after handover.
Specifically, responsibilities include:
- CAPEX Project Delivery Process leadership (PDP) for strategic programs and projects at the level of a single Business Unit or across the Cluster Business Units (projects typically ranging up to $10MM):
- Partners with Operations, Logistics, E&PS, EHS&S, Quality and/or other customers in the identification of business opportunities or needs.
- Partners with other MAM functions (Cluster Engineering Disciplines, Cluster Execution Systems, Cluster Risk Management, Maintenance BU’s in the Cluster, MAM CoE) and other functions (e.g. E&PS, EHS&S, Quality, IT, Global Procurement) to perform engineering design; translating identified business opportunities/needs into proposed engineering solutions; leveraging as much as possible standardized solutions for the Cluster.
- Coordinates with MAM Engineering Disciplines and MAM Execution System Engineers (automation) to ensure alignment with engineering standards and specifications.
- Coordinates with MAM Manufacturing Technology Engineering and Technical Operations to ensure alignment with process standards and engineering specifications for manufacturing technology.
- Partners with MAM Maintenance & Reliability engineering to ensure the project addresses maintenance requirements (detailed maintenance plans, spare parts, …) and the new or modified system performs in accordance with defined asset criticality.
- Partners with MAM Technical Safety and Compliance to ensure the proposed solution meets regulatory requirements.
- Partners with users in operations to translate user requirements into functional- and equipment specifications.
- Develops and presents the Pre-Project Definition (PPD) outlining the business opportunity or need, business drivers, investigated solution proposals, proposed preferred solution (and rationale), proposed project scope, timeline, resource requirements and financials, supporting business case, project risks etc.
- Develops associated CAR documentation and leads or supports project approval.
- Prepares the FPX project team kick-off and uses FPX best practices throughout the project.
- Owns the Project Delivery Process including detailed engineering design, change control, construction, commissioning & qualification, integration into maintenance (IIM), project hand-over to the user and project start-up.
- Ensures adherence to company policies and procedures, regulations, and customer specifications.
- Keeps stakeholders (including senior management) informed on project status, outlook, risks and established KPI’s for the project.
- Ensures timely delivery of project deliverables and documentation.
- Developing self as SM API Cluster Process Technology Subject Matter Expert (SME):
- Leads or participates in MAM Technology Teams to develop and secure expertise in specific technology areas and to drive technology standardization for the Cluster.
- Participates in joint JSC/DPDS Technology Stronghold Teams to support the development of new technology platforms for the Cluster.
- Provides ongoing operational support to the Maintenance Business Units in the Cluster for complex equipment related issues or project after care (2nd line support to Operations).
- Assists Reliability engineers and Maintenance BU teams in improving equipment reliability.
- Delivers technical requirements for new product introduction as well as driving continuous and breakthrough improvement of the product's supply chain capabilities.
- Acts as process and project engineering expert in large scale CAPEX projects where overall project management is owned by E&PS (projects typically above $10MM).
- Act as process specialist and JSC single point of contact to support external engineering company in the design, construction and start-up.
- Provide expertise to Platform and Enterprise level as required.
- Other responsibilities/assignments may include :
- Assuming Project Leadership for Business Optimizations projects (OPEX programs or projects, typically related to assets e.g. JJPS initiatives for the Manage Assets Business Processes).
- Development of a strategic Capital Master Plan and Long-Range Financial Plan for a given area.
- Acting as MAM Single Point of Contact (SPOC) for a strategic program (e.g. network optimization initiatives), for a given area, for an NPI or Product Life Cycle Management program (e.g. a Focused Factory) to maintain oversight over the related project portfolio.
- Training and coaching of external engineers on project delivery processes, technical standards and equipment specifications.
- Assuming Leadership for scoping, planning, scheduling and/or execution of a STOP (coordination of a portfolio of projects and maintenance activities executed during a shutdown or major overhaul).
- Acting as MAM SPOC for one or more external Service Providers (e.g. a managed service for engineering services) including acting as a gateway for assigned work, providing oversight over the portfolio entrusted to the external partner, management of communication flows, monitoring and improving of the service rendered, etc. …).
- Performing external manufacturing partner capability assessments as well as providing external manufacturing project support at external locations to drive the MTO/JSC priorities.
Required Knowledge, Skills and Abilities:
- Proven track record in capital project management and engineering in the life sciences industries is required including design, construction, commissioning and qualification, project hand-over and start-up. Experience with project management for large capital projects is desired (e.g. insight on required project organization, advanced tools for management of project related risks and tools for value engineering).
- Good insight in applied chemical unit operations and knowledge of applied SM API technology base is highly desired (multi-purpose batch reactor, product isolation and drying, particle tuning). Knowledge of advanced SM API technology platforms is a strong asset (e.g. PAT technologies, oligonucleotides and polypeptides, …).
- Experience with Facilities Engineering is highly desired.
- Ability to develop profound subject matter expertise in one or more technical core competence areas is required.
- Good insight in Asset Management, Maintenance & Reliability processes is required. A professional Asset Management certification (MAMC or equivalent) is an asset.
- Candidates possess strong leadership and communication skills, have demonstrated ability to bridge various technical and business disciplines and to deliver results in a matrix organization.
- Candidates have ability to maintain oversight and to zoom into detail as required; ensuring completion of significant programs and multiple projects running in parallel.
- Strong record of proactive global cross functional collaboration across the Cluster and across various levels in the organization (Management levels as well as shop-floor level).
- Proven change management leadership skills and track record of developing team members.
- Proficient in customer/supplier relationship management and management of multiple stakeholder groups.
- Proficient in partnering collaboratively with external engineering companies.
- Strong business acumen, familiarity with financial management (budgeting & costing) required.
- Knowledge of Process Safety Management requirements in chemical industry (functional safety, PED, SIL ...) and related risk management processes (HAZOP, SWIFT, FMECA, RCM ...) is required.
- Knowledge of quality requirements in pharmaceutical/life science industries is required.
- Good knowledge of English is required, both verbally and written.
- Responsible for overall project management and leadership of the project team. Accountable for achieving the Final Project Objectives (FPO’s).
- Delivers local projects, cluster project work streams or departmental programs successfully under limited supervision.
- Provides technical leadership, proactively identifies relevant customer needs and identifies and applies relevant safety and quality compliance guidelines, procedures and technical standards and ensures engineered solutions are fit for intended use and compliant with applicable regulation throughout the entire system life cycle.
- Identifies project financial requirements and proactively manages project spend in accordance with project scope and budget.
- Identifies required project activities and potential risks and proactively manages progress in accordance with project milestones and timelines.
- Presents (or assists in presenting) project proposals to Cluster and Platform management.
- Successfully manages and delivers multiple projects simultaneously. Independently plans and prioritizes activities for completion.
- Supports in defining MAM projects and/or program goals and tactics.
- Actively develops personal network, leverages internal and external expertise (suppliers, universities, …) to drive innovative engineering solutions.
- Benchmarks with other pharmaceutical companies and other industries to provide best in class engineering solutions.
- Drives superior outcomes by applying Faster Forward mindset and methodologies. Focuses on the customer and gains profound insights on customer needs. Collaborates across functional and business areas, pilots and learns fast from mistakes, boldly tries new E2E integrated solutions and builds fast track innovative and agile solutions.
- Continuously develops own technical knowledge by attending educational seminars and trade shows. Reviews professional publications and analyzes industry trends, explores new technologies and advises on modifications to Cluster Standards and/or Cluster project portfolio.
- Improves processes and/or project methodologies.
- A high degree of collaboration within MAM and other internal functions (MAM Manufacturing Technology Engineering, MAM Cluster Portfolio planning & prioritization, MAM Engineering Technical Administration, MAM Cluster Engineering Disciplines, MAM Cluster Execution Systems, MAM Cluster Risk Management (technical safety, technical compliance, maintenance & reliability engineering, Services Management), MAM Maintenance BU’s, MAM CoE, Operations, Logistics, E&PS, EHS&S, Quality, Technical Operations, IT and Global Procurement) is required to develop standards and to translate business opportunities/needs into adequate engineering solutions that meet all requirements and perform to customer expectations.
- Extensive collaboration with external partners (A&E firms, construction companies, preferred vendors and equipment suppliers, specialized contractors and consultancy firms) is required to establish roles and responsibilities, agree on requirements and expectations, coordinate project plans and execution of work, remove barriers etc. Development and maintenance of a good relationships with these partners is essential to ensure quality of work and compliance with all company policies and regulatory guidelines
- Internal and external competence centers (e.g. Academic institutions and training centers, industry consortia, professional associations …)
- Provides support to the J&J external supply chain network.
- Project Management Professional (PMP) or Flawless Project Execution (FPX) is highly desired.
- JJPS project management methodology (desired)
- MAMC (Manufacturing Assets Management Certification) by the JJSC Academy is an asset.
- Six Sigma/Lean certification/Faster Forward methodologies (desired)
North America-United States-Georgia-Athens, Europe/Middle East/Africa-Ireland-Cork-Cork
Janssen Pharmaceutica N.V. (7555)