Automated Production Operator 2nd Shift

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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 Automated Production Operator 2nd Shift, Performs chemical processing and batch mixing in a new state of the art automated manufacturing environment. Responsibilities include batch execution, in-process quality verifications, equipment cleaning, entering production activities in Oracle MRP system, product inspections, HMI input for robots, and providing support for other activities within the team. All processing operations are performed in ISO Class 7 area 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.

This is a second shift role (3:00 p.m. – 11:30 p.m.)

SUPERVISION RECEIVED: Under the direct supervision of the Operations Manager

SUPERVISION EXERCISED: NA

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Responsible for accurately maintaining accurate records, required logs 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.

• Performs and supports daily manufacturing operations inclusive of batch execution, product inspections, setup, operation, disassembly, and cleaning of manufacturing equipment.

• Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.

• Supports equipment maintenance and troubleshooting activities to minimize process downtime or re-occurrence. Support investigational activities around events/non-conformances or customer complaints.

• Supports equipment evaluations and validation activities associated with the developed manufacturing processes

• Communicate with team members and support teams to ensure continuous production of the correct product at high quality levels with minimal wasted time and materials

• Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.

• Interfacing with HMIs.

• Support department and plant Safety goals by continuously demonstrating safe behavior.

• Maintain, analyze problems, troubleshoot, and make adjustments to process equipment as needed and detect when equipment is not operating correctly.

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 with 2+ years of experience in the Medical Device industry or Pharmaceutical industry within a clean room environment preferred.
• Must work and collaborate as part of a team.
• Ability to operate, maintain and troubleshoot process equipment, and make adjustments as needed.
• Strong mechanical abilities as applied to an automated production line.

• Must read, write, and speak in English, and communicate clearly and concisely.

TOOLS AND EQUIPMENT USED

• Lyophilizers, homogenizers, HMI, pH meters, balances (scales), Steris Washer, Printers, Crosslink chambers.
• Oracle MRP System

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of 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, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds.

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.

• Daily interaction with hazardous materials used in a controlled environment.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

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.

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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].