PSC Biotech is hiring a Senior Project Engineer in Cork.
The Senior Project Engineer is responsible for all activities required to support the successful delivery of new engineering projects. Looking for a Senior Project Engineer 10 -15 years in a project engineering capacity in API environments
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 goals.
•Scope new Engineering projects & secure Capital approval
•Lead, support and participate in commissioning and qualification activities
•Participate in and lead Cross -Functional teams as necessary.
•Updating & influencing management and project stakeholders.
•Troubleshooting of process or equipment issues
•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 and or P&IDs
•Project Cost Management (estimation, forecasting, tracking, updating)
•Project Scheduling (creation, tracking & reporting)
•Project progress reporting & Risk Management
•Constructability & Maintainability/Operability studies
•Project Resource Management
•Reviewing current condition of systems (structural, E&I as well as safety, permitting and documentation)
•Organization & coordination of project meetings
•Investigating and resolving Deviations raised within the Engineering Department
•Provide process and equipment related training as required.
•Completion of assigned tasks to support manufacture of quality medicines in accordance with cGMP and EHS requirements.
•Retrospective project performance review vs project goals and lessons learned.
SCOPE OF RESPONSIBILITIES:
•Responsible and accountable for assuring the safe accomplishment of job activities, in compliance with corporate and cGMP/EHS regulatory requirements.
•Carry out routine and non -routine tasks delegated by the Manager according to appropriate procedures, values and standards.
•Compliance with Engineering and general site procedures at all times
•Completion of all documentation in compliance with site procedures and GDP
•Prioritize and scheduling of activities to support business needs and to meet requirements of Master Production Schedules
•Generate and assist with generation, review and revision of Engineering documentation as necessary.
•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.
•Travel to other J&J sites and other external sites for business related activities as required (?5%)
•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 teams as necessary to support site goals.
•Collaboration and teamwork
•Initiative and motivation
•Demonstrate Credo value of integrity.
•Work as a strategic partner with all other departments within the company.
Requirements
ORGANISATIONAL INTERFACES:
Interface at with all site departments, Operations, Maintenance, Facilities, Quality, MSAT, Commissioning/Qualification and Training departments.
QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL:
•Third level qualification in Engineering or Science.
•3+ years experience working in Pharmaceutical environment
•Experience of delivering engineering projects within a GMP regulated environment, specifically Pharma.
DESIRABLE:
•Qualification in Project Management
•6 -Sigma or similar problem solving/decision making methodology training
•Experience of working within an Engineering team in a multinational corporate environment.
•Experience of Microsoft Word, Excel and Outlook
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
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