Reporting to the Associate Director of Process Technology and dotted line responsibilities to the project Design Lead, the role will provide project and process design support to the project team to ensure that the project and process requirements are implemented to specification, time, quality and within budget for a successful handover to the end user. This individual will also assist in the development of project plans and contribute to project monitoring and control activities. This person will utilize their underlying knowledge in plasma fractionation to ensure the process design is captured appropriately to meet: Scope, Budget and Timelines.
You will be a member of the Process Technology team in Kankakee under the Global Process Engineering umbrella. You will join a team of Scientists and Engineers focused on Drug Substance production in a commercial Fractionation Manufacturing operation and that provides strategic technical direction to the manufacturing organization and project delivery team that allows the site achieve supply targets while maximizing capacity. As subject matter experts of the process, you will lead process design of capital process improvement in the fractionation process as well as supporting existing operational challenges as they arise. Daily work will be onsite in the Kankakee plant and will require approximately 50% travel to support the project design and equipment manufacturing process.
Responsibilities:
Responsible for process design activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet production throughput demands.
Support/lead multi-disciplinary teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements.
Provide cGMP compliant processes and facilities suitable for FDA and global regulatory approval.
Project teams are responsible for completion of project lifecycle activities through turnover to routine commercial production. This role would continue to support new projects and existing commercial product upon completion of the project.
Lead transition of technical oversight of the process from project (tech transfer) to operations phases for manufacturing.
Ensure that key parameters for process monitoring are clearly identified during the project design. Upon turnover, a control strategy is created and necessary charting of these parameters (e.g. time series, control charts) are set up and transferred to the Operations team.
Qualifications:
Bachelor's degree required. Degree in Engineering or Science discipline strongly preferred. Level of role determined by related industry experience (pharmaceutical/biotech operations preferred).
Minimum 5-6+ years of industry experience with Plasma Fractionation experience.
Knowledge of cGMPs and manufacturing operations in FDA regulated facility.
Understanding of project management principles and project lifecycle phases. Knowledge of Commissioning and Qualification, Process Validation, and facility regulatory submission requirements.
Strategic mindset and experience leading projects.
Experience leading multicultural and international teams is preferred.
Have strong technical writing skills.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
#LI-Onsite
The expected base salary range for this position at hiring is $104,000 - $118,400. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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