職位描述
This position is responsible for implementation of water systems and steam sterilizer operations. This individual will interface with the project team, facility lead and contractors to develop install and validate water systems and steam sterilizers to meet business needs around the world. This individual will need to understand and assist in the development of compounding mixes such as Saline, Heparin, Citrate or Chlorhexidine and provide technical support to validate processes and meet regulatory compliance. They would also assist with the development of standardized water system maintenance programs and steam sterilizers maintenance program.
LivingtheBDValues
We do what is right
We are committed to the highest standards of excellence and integrity in everything that we do: on behalf of our customers, our shareholders, our communities and ourselves. We are proud to work for a healthcare company whose products and services make a difference in people’s lives. We derive our greatest sense of accomplishment from doing what is right – not what is expedient. We don’t compromise our high standards of ethics in order to achieve our objectives. We are reliable, honest and trustworthy in all our dealings. We keep our promises and if we make a mistake we make it right.
We take personal responsibility
Change is never easy, and despite our best efforts, it won’t all go smoothly. Being individually responsible means we are accountable for our decisions, even when we make a mistake, and not try to place blame or make excuses. We treat the company’s reputation as our own and try to make wise use of our time and the company’s resources. We expect access to the tools and information necessary to participate in any decisions that will reflect on our collective or individual reputations.
We anticipate and address the challenges of patients and customers globally
It’s not enough to just respond to customer challenges. We need to know our customers’ needs as well or better than they do, so we can be proactive. Thinking about our customers holistically, including the patients they serve, will enable us to serve them better, helping to solve their most pressing healthcare challenges.
We innovate and improve continuously
Innovation isn’t specific to R&D and new product development, nor is continuous improvement limited to our operations and manufacturing teams. We are all accountable for seeking innovative solutions to our challenges and for not settling for “good enough” but striving to improve and be better every single time. We study our progress and learn from others and ourselves how to do things more effectively and efficiently.
We respect, collaborate, challenge and care about each other
We act with respect towards each other and towards those with whom we interact. We collaborate and challenge each other, cultivating best practices throughout the organization. We demonstrate constructive candor by disagreeing openly and dealing with our differences professionally. We care about people as individuals and promote an inclusive work environment that values, appreciates and leverages diversity.
RESPONSIBILITIES
Project Planning and Execution – Prepares and implements project or plans for areas of responsibility including but not limited to: new site expansion, upgrading older systems, quality improvement programs, new product support and other process improvements. The plan or proposal is to include the proposed technical approach, estimated implementation costs, estimated resource needs, and a time schedule, (Gantt chart). Acts as the driving force for the project, coordinating all resources and activities necessary to ensure on time execution to the project or process improvement plan, identify and work through barriers that hinder progress.
System Maintenance Planning and Coordination – Responsible for the development and implementation of a standardized maintenance program including system cleaning & passivation, spare parts and PM interval planning. Will work with sites to access and build capability through training and ensure the effective completion of tasks or improvement projects.
Technical Writing / Documentation – Must possess excellent technical writing ability. Required to prepare process job descriptions and manufacturing specifications, thoroughly documents all equipment, machines, and tooling with accurate and clear detailed prints and maintenance instructions.
Validation – Work with project Quality Engineer and validation team, must possess the ability to create all necessary documentation associated with the BD change control process and validation activities to ensure timely execution according to the project or process improvement plan.
Manufacturing Site Support – Provides technical guidance and leadership as needed to site personnel during the startup of new or updated systems and processes. Expected to use good decision making, professional interaction with problem solving and trouble-shooting techniques to train and mentor others in the resolution of manufacturing issues.
Capital Request / Capital Management – Prepares a plan for procurement of capital equipment including obtaining of quotes, vendor investigation, budgeting, and scheduling. Prepares specifications, place orders, coordinate procurement, install equipment, debug and coordinate the startup of new or modified equipment from outside firms or as modified internally, manages capital spending on assigned projects to ensure spending in accordance with the plan capital budget.
Design – Coordinate design activity with outside vendors or internal functions as necessary. Ability to perform own design and drafting tasks as required. Leads or oversees the redesign of existing equipment to incorporate improvements relating to safety, system reliability, product quality and cost. Must be able to design using the proper materials, piping, valves and filtration for the application.
Supervision / Leadership – Will indirectly provide leadership for all resources assigned to project team and interact with site Laboratory leader, Facility engineer, Engineering manager and or Plant manager.
- Bachelors of Science Degree in Chemical or Mechanical Engineering or a related engineering discipline from a recognized, accredited university or an Associate’s Degree in a related engineering discipline with greater than 8 years’ experience with high purity water systems or Water for Injection (WFI).
- Demonstrated ability to lead engineering projects related to capacity expansion or solution compounding development including mixes similar to Saline, Heparin, Chlorhexidine or Citrate.
- Knowledge of International Society Pharmaceutical Engineering, Current Good Manufacturing Practice and Food & Drug Administration guidelines and/or experience with facility systems including high purity water, clean compressed air, steam, electrical, solution compounding and pre-treatment systems.
