Job Description

Clean Room Manufacturing Operator

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.

The Clean Room Manufacturing Operator will perform post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, labeling, and boxing in order to produce the finished good. Also performs sub assembly post chemical processing such as crosslinking required to produce collagen-based products. All work streams include responsibility in the setup, operation and cleaning of all cleanroom manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Cleanroom gowning. All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations), Standard Operating Procedures (SOP's) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughout.

This is a second shift (3:00 p.m. - 11:30 p.m.), Monday through Friday role.

Under the direct supervision of the area supervisor and indirect supervision of the lead manufacturing operator.

None.

Essential Duties And Responsibilities

• 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 crosslinking, 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 cleanroom operations or ISO Class 7 cleanroom 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 Management 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.

Desired Minimum Qualifications

• High School diploma or equivalent. Degree in a related science a plus.
• 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.
• 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 cleanroom 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.
• Requires proficiency through job-related training and considerable on the job experience.
• May act as an informal resource for colleagues with less experience.

Tools And Equipment Used

Lyophilizers, Autoclave, Tornado Mil, 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.

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 a prolonged period 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 | 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 careers@integralife.com or call us at 855-936-2666.

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