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Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

The Lead, Cleanroom Manufacturing will provide daily direction to the manufacturing floor based on production schedule, available resources, and department priorities. Engage and support manufacturing process to assure timely completion and quality throughput. Lead and support administrative activities such as training, investigations, procedure development, and inventory management within the manufacturing area. Drive a positive culture within the manufacturing environment through teamwork, engagement, and respect.

SUPERVISION RECEIVED

Under direct supervision of the Supervisor, Packaging Operations.

SUPERVISION EXERCISED

Indirectly supervise the Manufacturing Operators. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

People

• Allocate resources to meet daily schedule needs and support recover plan development and execution.

• Partner with area management to identify overtime needs in advance.

• Communicate with support groups on daily processing needs.

• Provide feedback to department management on operator and process performance.

• Interface with support departments to establish clear/consistent manufacturing objectives and needs.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Process

• Perform all requirements of a Cleanroom Manufacturing Operator.

• Provide daily oversight of manufacturing operations in the skin suite.

• Actively engage in all areas of the manufacturing process.

• Identify and resolve training gaps (process, performance, paperwork) through the execution of a training plan.

• Own operator training for all new Cleanroom Manufacturing Operators.

• Lead troubleshooting initiatives to minimize equipment/process downtime.

• Perform manufacturing suite walk through activities to identify equipment deficiencies and observe operator execution.

• Support investigations as a subject matter expert.

• Maintain process and component inventories.

• Support time management around start/stop, breaks and timely completion of tasks.

Paperwork

• Obtain batch records in advance for associated manufacturing operations to prevent delays.

• Document manufacturing activities in real time and perform daily in-process checks of paperwork.

• Supply and receive paperwork from support groups when necessary to keep manufacturing operations on track and progressive.

• Perform daily, in-process reviews of batch records to support good documentation practices.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability desired for this position.

• High School diploma or equivalent. Degree in related science a plus.

• 3-5years of chemical processing experience or batch mixing in manufacturing environment in the Medical

Device or Pharmaceutical industry preferred.

• Basic computer skills for email and data entry.

• Must read, write and speak in English, and communicate clearly and concisely.

• Fundamental understanding of mathematics and chemistry.

• Able to participate in a team-oriented environment, willingness to assist and train others.

• Able to work independently with minimal supervision.

• Understand product flow and understand chemical processes and its impact.

• Able to work overtime.

TOOLS AND EQUIPMENT USED

Lyophilizers, homogenizers, Tornado Mill, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, humidity cabinet, centrifuge, blenders, air gun, Filamatic filling machines, drop indicator, scalpels, pouch sealers, and temperature chart recorders.

PHYSICAL REQUIREMENTS

• Ability to gown to ISO Class 5 type Clean Room standards and/or additional cleanroom clothing.

• Ability to gown to ISO Class 7 type Clean