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SUMMARY DESCRIPTION

This Clean Room Manufacturing Lead Operator role will include processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization. It is essential to perform these tasks meticulously to ensure the quality of our products.
Additionally, you will be responsible for the setup, operation, and cleaning of all clean room manufacturing equipment. This entails working in ISO Class 5 or ISO Class 7 areas and adhering to Clean Room gowning protocols. All operations must be conducted in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements.
Operating in a team environment, we emphasize daily achievements and maintaining high-quality standards in our production processes. Encourage teamwork and open communication as we work towards our daily goals. Your dedication is crucial to our collective success. Additionally, engage in administrative activities such as training, investigations, and inventory management within our manufacturing area.

This is a Monday to Thursday role, shift is 6am to 4:30pm

ESSENTIAL DUTIES AND RESPONSIBILITIES

People

• Allocate resources to meet daily schedule needs and support 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

Process

• Perform all requirements of a Manufacturing Operator
• Provide daily oversight of the medical manufacturing operations
• 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
• Identify equipment deficiencies and observe operator performance in manufacturing
• 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 maintain manufacturing operations on a consistent and progressive basis
• 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

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 related to science.
• 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.

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills required of position 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.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions which the employee may be exposed to 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.

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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 | EOE including Disability/Protected Veterans

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. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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