Job Information
Integra LifeSciences 2nd Shift Lead Operator in Plainsboro, New Jersey
Changing lives. Building Careers.
Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
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 to 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
Process
Perform all requirements of a Manufacturing Operator
Provide daily oversight of manufacturing operations in the 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 Chemical 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
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.
3-5 years 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 process 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 Honeywell temperature recorders
PHYSICAL REQUIREMENTS
Ability to gown to ISO Class 5 type Clean Room standards and/or additional Clean room clothing.
Ability to gown to ISO Class 7 type Clean Room standards and/or additional Clean room 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.
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 limited to, flammable and corrosive liquids, compressed gases, and medical wastes.
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
Provide comments in batch records not limited to non-conformance references or other clarifications
Perform daily, in-process reviews of batch records to support good documentation practices
Develop, redline, and/or review associated manufacturing documentation
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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