*********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
SIGNIFICANT ENVIRONMENTAL, HEALTH & SAFETY CONSIDERATIONS:
All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act, all employees are required to:
•Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
•Compliance with EHS rules and procedures at all times.
•Understand the potential EHS impact of their activities.
•Attend and participate in EHS training as required.
•Use PPE and safety equipment as required.
•Report all incidents, accidents, and near miss events.