Clean Room Manufacturing Operator-1st Shift
Company: Integra LifeSciences
Location: Plainsboro
Posted on: April 16, 2024
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Job Description:
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.
Operate, maintain, and troubleshoot process equipment utilized in
the collagen business, and be able to make minor equipment
adjustments as needed.
Responsible for performing precise measurements and using
measurement equipment to accurately add chemicals to batches.
Responsible for the cross linking, cutting, packaging and boxing of
the product in its finished goods form, which includes performing
visual product and component inspections to identify and remove
defects.
Pass and maintain gowning qualification to perform Gowning
Requirement for ISO Class 5 Clean room operations or ISO Class 7
Clean room operations.
Responsible for accurately maintaining legible and accurate
records, required logs, books, records, and other procedures to
comply with regulatory requirements, Good Manufacturing Practices
(GMP), Quality Systems Regulations, Standard Operating Procedures
(SOP's), and Health and Safety requirements.
Interface with QA/QC/Material departments during course of work to
coordinate inspections and efficient flow of subassemblies and
completed product.
Enter and record production activities in Oracle MRP systems to
issue material and labor hours to specific work orders.
Follow applicable Standard Operating Procedures, Quality System
Regulations and ISO 13485 requirements.
Qualifications:
High School diploma or equivalent. Degree in a related science a
plus.
0 - 2 years of chemical processing experience or batch mixing in
Medical Device or Pharmaceutical manufacturing industry. Production
experience is highly desirable.
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.
Ability to operate, maintain and troubleshoot process equipment,
and make minor adjustments as needed.
Ability to gown to ISO Class 5 and 7 Clean Room standards.
Able to work overtime.
Support department and plant Safety goals by continuously
demonstrating safe behavior.
Maintain a clean and orderly work area.
Ability to work flexible shifts, and flexible days within the week
to meet batch milestone requirements.
Perform other manufacturing activities as assigned by the
department leadership.
TOOLS AND EQUIPMENT USED
Lyophilizers, Autoclave, homogenizers, grinder, vacuum pump, pH
meters, thermometers, balances (scales), water bath circulators,
sonicators, humidity cabinet, mixers, centrifuge, blenders, air
gun, drop indicator, Filamatic filling machines, slicer machines,
scalpels, temperature recorders, Crosslinking chamber,
humidification chamber, compression unit, cutting table, sealing
machines, shrink wrap machines.
The employee must be able to stand for 8 hours, lift up to 60lbs
and climb ladders without assistance. The employee is required to
go to all areas of the company.
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.
Must be able to climb step ladders without assistance.
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.
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.
Integra - Employer Branding from Integra LifeSciences on Vimeo
(https://player.vimeo.com/video/265760526)
Keywords: Integra LifeSciences, Levittown , Clean Room Manufacturing Operator-1st Shift, Other , Plainsboro, Pennsylvania
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