Director E&PS EMST

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/

J&J E&PS PD-IM is recruiting for a Director E&PS EMST (Ext. Manufacturing Support Team) reporting to the Senior Director Strategic Projects Delivery and to be based in: Italy, Netherlands, Belgium or Ireland.

The Director E&PS EMST is responsible for Leading the External CMO Facilities assessment (Fit to Plant - F2P) and Hypercare events with a small Team of SMEs (local and/or regional) ensuring consistency with stakeholder business strategy, commitments and goals in alignment with E&PS Standard Design Platforms. This includes the following responsibilities:

• Be Customer & Partner Centric.
• Establish & Maintain a Robust Partnership with JSC PES Organization
• Full working knowledge of Project Management processes required in the design and execution of field construction activities including, but not limited to safety, quality, project controls, and commissioning, qualification and validation of FDA and other agencies regulated facilities including technology transfer and regulations governing product manufacturing.
• Experience and full working knowledge of field construction activities, schedule development, construction safety methodologies, functional disciplines, RFP development, descoping and award of contracts including understanding of contract language and associated legal implications.
• Strong experience and capabilities in J&J manufacturing processes (Pharma, Medical Device, Consumer).
• Strong experience and capabilities in J&J Real Estate and Facilities Management processes.
• Define, identify, and secure appropriate internal and external resources and coordinate the efforts of team members and third-party contractors or consultants to assure CMO Facilities always meet J&J Standards.
• Strong management and technical skills.
• Demonstrate knowledge and expertise in bridging technical and business disciplines.
• Assemble and coordinates project teams and manages project resource allocation.
• Define project tasks and resource requirements and develop full scale project plans as applicable (for Hypercare events).
• Full understanding of Project Controls and financial assessments required for Capital Appropriation submissions.
• Track project deliverables using appropriate tools. Monitors and report on progress of the project to all stakeholders.
• Ensure that proper risk management analysis is performed, and plans are in place for all projects and technology implementations.
• Provide status reports defining project progress, risks and mitigation plans.
• Implement and manage project changes and interventions to achieve project outputs.
• In the event of gaps and/or upset Facilities events, defines scope, Manage project budget, drive results and conducts project evaluations and assesses results.
• Ensure metrics for engineering performance are met and plans are in place to provide continuous improvement.
• Ensures collaboration of the Engineering and Technology group across other functional areas, establishing effective working relationships with partners.
• Ensure application of efficient work practices for core group processes and ensure continuous improvement and update of these practices by incorporating lessons learned.
• Understanding and familiarity with clean and plant utilities, computer systems and J&J Quality system documentation inclusive of CSV requirements in preparation for operations readiness.
• Ability to interact in multicultural environment.
• Comply with all training requirements to perform duties of the job.

Qualifications:

• Previous experience interacting with or managing Contract Manufacturers Facilities or Internal Manufacturing Facilities
• Bachelor’s degree in Engineering, Process, Architecture or Construction Management from an accredited institution is required.
• Minimum of 15 years of relative business experience within the pharmaceutical industry and project and operations management is required.
• People management experience is a nice-to-have
• Prior experience managing major capital ($10MM to $100MM) projects in Supply Chain, R&D, Distribution Centers and Offices is required.
• A full working knowledge of Project Controls in cost and schedule development and financial assessments is required.
• Deep knowledge of EU ANNEX 1 and ISPE guidelines
• LEED AP certification is preferred. PMP or comparable Certification and familiarity with J&J Project Management approaches (FPX & IDEA Process) is preferred.
• Manufacturing experience in FDA or other regulated environments from design through startup is required.
• Fluent knowledge of English language (writing and speaking)
• Experience and skills on contracting and negotiation is required.
• Experience managing project budgets and schedules is required.
• Experience working and collaborating with Real Estate, Finance and Facilities Management is required.
• This position may require up to 75% travel primarily in the EMEA region, with potential for occasional cross-continent travel.

This position may require up to 75+% travel primarily within EMEA region, with potential for occasional Global travel.