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Senior Project Engineer (Api Pharma)

Senior Project Engineer (Api Pharma)

Kenny-Whelan & AssociatesCork, Ireland
30+ days ago
Job description
  • LONG TERM CONTRACT ROLE - 5 to 10 YEAR DURATION AT API MANUFACTURING SITE
  • JOB DESCRIPTION POSITION SUMMARY :

    As part of the Engineering Project Delivery Team, this contract position is responsible for all activities required to support project scoping, commissioning, qualification, validation and start-up operations within the API manufacturing site.

    These activities include but are not limited to :

    GENERAL ACTIVITIES :

    • Lead the delivery of Engineering projects on time, on budget & in accordance with all project & business Safety & Quality goals.
    • Scope new Engineering projects & secure Capital approval
    • Lead, support and participate in commissioning and qualification activities both current and future projects.
    • Updating & influencing management and project stakeholders.
    • Coordination of the participation of specialist trades and specialist departments
    • Coordination of project interfaces with other projects and departments
    • Coordination of and interfaces with third parties (suppliers, customers, service providers, etc.)
    • Coordination of project documentation
    • Cost Estimation (creation, tracking, updating, auditing vs actual Costs, forecasting)
    • Project Scheduling (creation, tracking, updating, review vs current state, forecasting)
    • Project progress reporting & Risk Management
    • Constructability- & Maintainability- / Operability-studies
    • Project Resource Management
    • Checking the current condition of systems (structural, E&I as well as safety, permitting and documentation)
    • Organization & coordination of project meetings and appointments
    • Provide project related training as required .
    • Completion of projects in accordance with J&J Change Management Procedures
    • Retrospective project performance review vs project goals and lessons learned.
    • Participate in and lead Cross-Functional teams as necessary.
    • SCOPE OF RESPONSIBILITIES :

    • Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures.
    • Commit to and demonstrate safe behavior in every activity.

    • Carry out routine and non-routine tasks delegated by the Manager according to appropriate procedures, values and standards .
    • Carry out all activities in compliance with corporate and cGMP / EHS regulatory requirements.
    • Compliance with Engineering and general site procedures at all times
    • Completion of all documentation in compliance with site procedures and GDP
    • Prioritize and schedule activities to support business needs
    • Ensure that personal training requirements are completed in compliance with site procedures .
    • Support ongoing studies by Operations, Quality Validation, MSAT, Facilities and other support functions .
    • Support external site visits as required for project related activities.
    • Lead by example and strive to perform to high standards at all times.
    • LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION :

    • Report to Principal Project Delivery Engineer / Engineering Manager
    • Be familiar with daily activities in all areas of Manufacturing .
    • Facilitate an environment of continuous improvement.
    • Facilitate an environment of open communication.
    • Lead investigations in work area as necessary .
    • Lead Cross-Functional project teams to support site goals .
    • Collaboration and teamwork
    • Initiative and motivation
    • Share ideas and suggestions for improvement and encourage others to do the same.
    • To work as a strategic partner with all other departments within the company.
    • ORGANISATIONAL INTERFACES :

      Interface at with all site departments, Operations, Maintenance, Facilities, Quality, MSAT, Commissioning / Qualification and Training departments.

      Contact with other J&J sites .

      Be conscious of internal customers to Engineering department and work to fulfill their requirements.

      QUALIFICATIONS AND EXPERIENCE :

      ESSENTIAL :

    • Third level qualification in Engineering, Microbiology, Biochemistry, Biotechnology, or Science.
    • DESIRABLE :

    • Experience of delivering engineering projects within a GMP regulated environment.
    • Qualification in Project Management
    • Experience of Microsoft Word, Excel and Outlook
    • Experience of SAP, LIM's and / or other business systems
    • 6-Sigma / Kepner-Tregoe or similar problem solving / decision making methodology training
    • Experience of working within an Engineer team in a multinational corporate environment.
    • KEY COMPETENCIES REQUIRED :

    • Ability to operate as part of a team is critical.
    • Excellent Interpersonal Skills
    • Customer focus
    • Innovative
    • Mechanical / Technical aptitude
    • Excellent communication skills both written and verbal.
    • Attention to detail.
    • Good problem-solving skills.
    • Results and performance driven.
    • Adaptable and flexible
    • #J-18808-Ljbffr

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