Long Term Contract Role - 5 to 10 Year Duration at API Manufacturing Site
Job Overview:
This contract position is part of the Engineering Project Delivery Team, responsible for all activities required to support project scoping, commissioning, qualification, validation, and start-up operations within the API manufacturing site.
Key Responsibilities:
• Lead the delivery of engineering projects on time, on budget, and in accordance with all project and business safety and quality goals.
• Scope new engineering projects and secure capital approval.
• Participate in commissioning and qualification activities for current and future projects.
• Update and influence management and project stakeholders.
• Coordinate the participation of specialist trades and specialist departments.
• Coordinate project interfaces with other projects and departments.
• Coordinate with third-party suppliers, customers, service providers, etc.
• Coordinate project documentation.
• Conduct cost estimation (creation, tracking, updating, auditing vs actual costs, forecasting).
• Manage project scheduling (creation, tracking, updating, review vs current state, forecasting).
• Provide project progress reporting and risk management.
• Perform constructability- and maintainability-studies.
• Manage project resources.
• Check the current condition of systems (structural, E&I as well as safety, permitting, and documentation).
• Organize and coordinate project meetings and appointments.
• Provide project-related training as required.
• Complete projects in accordance with J&J Change Management Procedures.
• Conduct retrospective project performance reviews vs project goals and lessons learned.
Scope of Responsibilities:
• Responsible and accountable for ensuring 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.
• Comply with engineering and general site procedures at all times.
• Complete 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.
• Familiarize yourself with daily activities in all areas of Manufacturing.
• Facilitate an environment of continuous improvement.
• Facilitate an environment of open communication.
• Lead investigations in the work area as necessary.
• Lead Cross-Functional project teams to support site goals.
• Collaborate and work as a team member.
• Demonstrate initiative and motivation.
• Share ideas and suggestions for improvement and encourage others to do the same.
• Work as a strategic partner with all other departments within the company.
Organizational Interfaces:
Interface 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 the 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.
• Comply 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.