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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 Room standards and/or additional cleanroom clothing.

• Vision: Requires eyesight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all of quality reclassification. Requires normal color perception.

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required for this position. In order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee may be required to periodically lift 25 lbs. The employee may be required to stand for prolonged periods of time.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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