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 Manufacturing and Technical Operations 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 small molecules API MAM Cluster Engineering Team, responsible to deliver projects in Belgium (Geel), Ireland (Cork) and the US (Athens GE). 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/or projects at the level of a single Business Unit or across different Business Units (projects typically ranging from $50K up to $500K):
- Partners with Operations, Logistics, facility, EHS&S, Quality and/or other customers in the identification of business opportunities or needs.
- Coordinates with MAM Engineering Disciplines 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 project team kick-off and uses FPX (J&J procedure for project kick-off) 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):
- 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.
- Other responsibilities/assignments may include :
- Training and coaching of external engineers on project delivery processes, technical standards and equipment specifications.
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 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)
- Insight in Asset Management, Maintenance & Reliability processes is required.
- 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.
- 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.
- Good 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.
Janssen Pharmaceutica N.V. (7555)