- CAD Software
- Health Insurance
- Vision Insurance
- Retirement Plan
- Life Insurance
- Dental Insurance
This position is responsible for providing the managerial and technical expertise necessary to direct the efforts of a project team. The project team consists of contractors from various crafts as well as members of department as assigned. Responsibilities include analysis, recommendation, implementation, cost justification and follow-up on projects designed to increase or improve productivity, capacity, or safety.
Responsible for design and implementation of Instrumentation and Controls for Critical Utility, Batch and Continuous Process systems in Pharmaceutical Fill/Finish facilities.
Analyzes production and processing problems and initiate project definitions to resolve them.
Ensures timely and within budget completion of the projects as assigned by his/her manager.
Evaluates the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects.
Assures that assigned projects are in compliance with State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste-related issues.
Communicates and reports status of each project to the management and department that sponsors the project.
Maintains awareness of current pharmaceutical manufacturing needs and standards and initiates programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.
Directs and coordinates activities of various vendors for each project to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations.
Prepares URS, Risk Assessments, Safety Assessments associated with the project.
Oversees the execution of the project(s).
Identifies and Implements process improvements.
Identifies and specifies process-specific equipment.
Troubleshoots amends and accommodates the process of aseptic formulation and distribution of critical utilities.
IND-1; #CB; #GD
BS in Engineering, Preferably in Electrical, Computer, Chemical or Mechanical Engineering.
5 years hands on Instrumentation and Controls design experience for batch or continuous process systems.
5 years hands on Programming experience of Distributed Control Systems.
5 years hands on experience with validated manufacturing process systems.
Experience in drafting process flow diagrams for Automated Batch, Continuous Process and Formulation systems.
Experience in Designing, programming and supporting PLC, HMI and SCADA software for control systems and equipment.
Expertise in specifying instrumentation such as valves, pressure reducers, temperature and pressure transducers and other process relevant instrumentation in sanitary process equipment.
Expertise in specifying Controls and I/O hardware for distributed control systems.
Full programming proficiency in at least one major DCS Brand. Preferably Rockwell Automation PlantPax or Siemens PCS7 and their associated SCADA software.
Good understanding of common industrial communication protocols such as Ethernet/IP, Modbus TCP/IP, ProfiNet or other IEC-61850 compliant protocols.
Working knowledge of AutoCad, SolidWorks and Navisworks
Knowledge of Clean Room Classifications and process flow is a plus.
Project Management experience in a food, pharmaceutical or regulated environment preferred.
Experience with critical utilities (WFI, OFCA, Clean Steam, HVAC) is desired.
CIP/SIP experience is desired.
Excellent verbal and written communications skills.
Excellent Presentation Skills.
IND-1; #CB; #GD
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.