Manufacturing Operator I - Collagen

INTEGRA CI INC; Añasco (PR); On-site; USD 14,000 - 19,000; Full time

Job summary

Integra LifeSciences is seeking a Manufacturing Operator I - Collagen to support enzymatic and alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization in ISO-class clean rooms. The role emphasizes GMP compliance, proper gowning, and meticulous production to maintain high-quality products.

Responsibilities include operating and cleaning clean room equipment, labeling materials, inspecting products for defects, and following SOPs.

Qualifications

• High School diploma or equivalent.
• Degree in related science a plus.
• 0 - 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.
• Production experience in a clean room environment is highly desirable.
• Able to read, write and speak English clearly.

Responsibilities

• Writes labels for all materials, components, and products with identifying information.
• Reads shop orders, blueprints, and procedures for specifications.
• Fills information on the documentation such as Shop Orders, etc.
• Cleans and maintains work area and tools.
• Assists group peers to complete tasks and meet schedules.
• May perform other tasks as requested by supervisor.

Skills

English fluency

Teamwork

Basic computer skills

Math & chemistry basics

Education

High School Diploma

Science degree a plus

Tools

Lyophilizers

Autoclave

pH meters

Centrifuge

Slicer machines

Job description

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.

Job Description

This Manufacturing Operator I - Collagen role will include processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization. It is essential to perform these tasks meticulously to ensure the quality of our products. Additionally, you will be responsible for the setup, operation, and cleaning of all clean room manufacturing equipment. This entails working in ISO Class 5 or ISO Class 7 areas and adhering to Clean Room gowning protocols. All operations must be conducted in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements. Operating in a team environment, we emphasize daily achievements and maintaining high-quality standards in our production processes. Your dedication and attention to detail will play a valuable role in our success.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Writes labels for all materials, components, and products with identifying information such as Description, Quantity, Name, etc.
• Cuts collagen sponges to specific size using cutting equipment/tool.
• Inspects collagen products for defects, surface pattern, razor cuts, open edges, or foreign matter visually using the spot lights. Also inspect for thickness using the required measurement gage.
• Packs products as instructed in shop orders or procedures using Alloyd sealing machines.
• Reads shop orders, blueprints, and procedures for specifications.
• Fills information on the documentation such as Shop Orders, etc. as required.
• Assists group peers in order to complete assigned tasks.
• May perform other tasks as requested by supervisor.
• Assemblers are required to work on priority orders when released before others in order to meet production schedules.
• Assemblers are responsible for achieving established productivity levels and quality standards.
• Follows Clean Room Rules and Gowning Practices.
• Uses the required protective equipment of the assigned workstation.
• Follows Production Order Instructions and the established manufacturing specifications of Drawings, Procedures, and Shop Orders.
• Maintains work area and tools clean and organized at all moments.

DESIRED MINIMUM QUALIFICATIONS

• High School diploma or equivalent.
• Degree in related science a plus.
• 0 - 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.
• Production experience in a clean room environment 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.

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 required of 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 must be able to stand for 8 hours, lift up 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 on a daily basis. Ability to gown to ISO Class 5 Clean Room standards and/or additional Clean room clothing. Ability to gown to ISO Class 7 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 eye sight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all the quality reclassification. Requires normal color perception.

Salary Pay Range

Salary Pay Range: $10.50 - $13.46 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.

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. 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 [e-mail].

Employer Branding

Integra - Employer Branding from Integra LifeSciences on Vimeo Whatever your specialty, you'll find an ideal setting for building a rewarding career. Along the way, you'll have the satisfaction of knowing your work matters, that it's making patients' lives better, making a positive and lasting difference. You'll find that the pace is exhilarating - because the need is so urgent. You'll be challenged - and supported - by the most dynamic and inspiring people in your profession. And you'll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we're a great place to build a career. Here's your chance to discover that for yourself.