Job 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. J&J E&PS PD-IM is recruiting for a
Director E&PS EMST
(External Manufacturing Support Team) reporting to the Senior Director Strategic Projects Delivery and to be based in: Italy, Netherlands, Belgium or Ireland. Responsibilities
Lead 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. Be Customer & Partner Centric. Establish & Maintain a Robust Partnership with JSC PES Organization. Maintain 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 in J&J Real Estate and Facilities Management processes. Define, identify, and secure appropriate internal and external resources and coordinate efforts of team members and third-party contractors or consultants to assure CMO Facilities always meet J&J Standards. Assemble and coordinate project teams and manage project resource allocation; define project tasks and resource requirements and develop full scale project plans (for Hypercare events). Full understanding of Project Controls and financial assessments required for Capital Appropriation submissions; track project deliverables and report progress to stakeholders. Ensure proper risk management analysis and have plans for all projects and technology implementations; provide status reports defining progress, risks and mitigation plans. Implement and manage project changes and interventions to achieve project outputs; in case of gaps or upset Facilities events, define scope, manage project budget, drive results and conduct evaluations. Ensure metrics for engineering performance are met and establish plans for continuous improvement; ensure collaboration across Engineering and Technology with other functional areas. Ensure application of efficient work practices for core group processes and update these practices by incorporating lessons learned. Understand and familiarize with clean and plant utilities, computer systems and J&J Quality system documentation including CSV requirements in preparation for operations readiness. Ability to interact in a multicultural environment and comply with all training requirements to perform duties. 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. 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 (writing and speaking). Experience and skills in contracting and negotiation is required. Experience managing project budgets and schedules is required. Experience working 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. Note: This description reflects the current responsibilities and qualifications for the role and does not imply a binding contract. Referrals increase your chances of interviewing at Johnson & Johnson. Get notified about new Director jobs in Beerse, Belgium. This posting may include additional locations and is subject to change.
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