The Plant Engineer provides the technical knowledge and is accountable for planning, coordination, and execution of technical activities needed to support Manufacturing Operations in the Final Product Manufacturing (FPM) department.
Plan, direct, coordinate and execute activities concerned with Production Support.
Demonstrate high level of urgency and is able quickly adapt to changing priorities.
Optimize production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements.
Provide key technical input for the definition of concepts for new plants, improvement of existing equipment and/or the identification of alternative equipment or installations.
Ensure production equipment uptime through preventive or predictive measures as well as small modifications and repairs.
Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment.
Establish, initiate and analyze preventative maintenance (PM) and calibration programs.
Collect, analyze and report equipment downtime information.
Identify, report and ensures resolution of critical equipment items.
Develop, review and implement recommendations to improve reliability of infrastructure and production systems.
Specification and strategy of spare parts needed to meet reliability objectives.
Coordinate maintenance activities and shutdown requirements for FPM production equipment and facilities.
Project management and detailed engineering of smaller projects (AFE, <$1 million) including planning, detailed design, procurement, construction management, quality, budget and optimization.
Provide plant and production input and project engineering support for large projects, (AR, >$1 million).
Perform installation and operational commissioning and qualification testing of equipment and systems.
Participate in audits conducted by internal and external agencies.
Perform Risk Assessments and resolution of risk analysis.
Understand relevant SOPs, Guidelines and Regulatory requirements.
Coach and teach junior members of the department and provide input to performance evaluations.
Make independent decisions within defined areas of responsibility.
Serve as a consultant to management within a specified area/discipline.
Advance technical project proposals to senior management, follow through to successful completion.
Develop network of external contacts appropriate to job.
Formulate and manage own career path.
Bachelor of Science Degree from an accredited college or university in Chemical, Electrical, Mechanical Engineering, or a closely related field.
BS 8+ years, MS 2-6+ years, PhD 0-4 years or an equivalent combination of education and experience.
Professional registration and/or certifications as appropriate.
Flexibility to support business requirement of rotational on-call support and / or weekend coverage.
Demonstrated ability to troubleshoot complex equipment / systems and supporting utility services.
Experience with regulatory and cGMP requirements for pharmaceutical manufacturing.
Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems, etc.
Knowledge of Bulk Formulation, Sterile Filling, Lyophilization, Packaging and Warehouse Technologies.
Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems.
Experience with FAT, SAT, Commissioning and Qualification, including hands on experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages.
Understanding of industry guidelines, regulatory requirements, and relevant SOPs.
Proficient computer skills to include Excel, Word and PowerPoint.
High level of urgency and is able quickly adapt to changing priorities.
Ability to troubleshoot equipment failures immediately and communicate status to engineers and production.
Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
Strong planning and organizational skills.
Good oral and written communication skills.
Strong interpersonal skills to effectively communicate with a diverse wide customer base.
Experience of Clean Utilities, Water for Injection and Clean Steam Generation Systems.
Experience on Clean Room Systems, HEPA and ULPA filtration for class 100 areas, be familiar with particle counting and HEPA filter testing and air balancing to achieve pressure differentiation among different room classifications.
Experience with cold rooms and refrigeration systems, chillers and cooling towers.
Experience with Boilers and Steam systems, such as condensate return skids.
Experience with Building Automation Systems (BAS).
Understanding of P&ID's and Blueprints for equipment troubleshooting.
SAP experience helpful.
Reliability engineering experience, including but not limited to development of equipment preventive and predictive maintenance strategies, Bill of Material development and Inventory optimization for spare parts.