Manufacturing Operator I

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 I will perform pre and post-formulation processing such as blending, mixing, pouring, loading, 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 for 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 (QSR), Standard Operating Procedures (SOP’s) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughout. 

This role is for our 12 hour weekend shift that is 6am to 6:30pm on Friday, Saturday and Sunday. (36 hours but paid for 40 hours)

SUPERVISION RECEIVED 

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

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 to blend, mix, pour, and load collagen prepped material into lyophilizing equipment.

• 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 (QSR), 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 

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. 

• 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. 

• 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), timers,  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 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 prolonged periods 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. 

Salary Pay Range:

$19.19 - $25.43 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 https://jobs.integralife.com/total-rewards/

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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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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