LONG TERM CONTRACT ROLE - 5 to 10 YEAR DURATION AT API MANUFACTURING SITEJOB 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
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