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 involving design of pharmaceutical parts washers and steam sterilizers.
Assists in process design and development of component preparation processing equipment.
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 report 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).
Develops and maintains process instructions for manufacturing equipment in accordance with site Change Control and Validation requirements.
Identifies and Implements process improvements.
Responsible for the process design and development.
Identifies and specifies process-specific equipment.
Troubleshoots, amends and accommodates the process of washing and steam sterilization of liquid fill components.
BS in Engineering.
3 years plant manufacturing experience.
3 years hands on experience with validated manufacturing process systems.
Experience with Aseptic Component Preparation, Automated Steam Sterilizers and Pharmaceutical grade Parts Washers.
Working knowledge of AutoCad or SolidWorks.
Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design.
Familiar with State, Federal and local codes.
Project Management experience in a food, pharmaceutical or regulated environment desired
Experience with clean room personnel and material flows desired.
Experience with critical utilities (WFI, OFCA, Clean Steam, HVAC) desired.
CIP/SIP experience desired
Knowledge of Clean Room Classification desired
Process Control and Instrumentation experience desired.
Excellent verbal and written communications skills.
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.