Manufacturing Operator II

Changing lives. Building Careers.
 

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 Manufacturing Operator level II performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, and labeling and boxing to produce the finished good. Also performs sub assemble post chemical processing such as cross linking required to produce collagen-based products. All work streams include responsibility in the setup, operation, and cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Clean Room 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.

Shift works Monday - Thursday 1st shift, 10 hour days

• Performs the setup, operation, and cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Clean Room 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.
• Blend, mix, pour, and load collagen prepped material into lyophilizing chambers.
• 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.

DESIRED MINIMUM 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.

PHYSICAL REQUIREMENTS

• The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require 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.
• While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee must be able to stand for 8 hours, lift to 60lbs and climb ladders without assistance. The employee is required to go to all areas of the company.
• Must be able to bend and lift 30 to 60 lbs without assistance daily.
• 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.
• Ability to stand for 8 hours.
• Must be able to climb step ladders without assistance.
• 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.

Salary Pay Range:

$21.12 - $27.98 USD Hourly

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.

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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.

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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