Lead Manufacturing Operator

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.

This Lead Manufacturing Operator will provide daily direction to the manufacturing floor based on production schedule, available resources and department priorities. Engage and support manufacturing process to assure timely completion and quality throughput. Lead and support administrative activities such as training, investigations, procedure development and inventory management within the manufacturing area. Drive a positive culture within the manufacturing environment through teamwork, engagement and respect.

Supervision Exercised

This role will lead Clean Room Operators

Essential Duties And Responsibilities

People

• Allocate resources to meet daily schedule needs and support recover plan development and execution
• Partner with area management to identify overtime needs in advance
• Communicate with support groups to 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 manufacturing operations in the suite
• 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
• Perform manufacturing suite walk through activities to identify equipment deficiencies and observe operator execution
• 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 keep manufacturing operations on track and progressive
• 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

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

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 in related science a plus.
• 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 require of 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.

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.

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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