Manufacturing Operator I - Collagen

Integra LifeSciences Corporation; Añasco (PR); On-site; USD 14,000 - 19,000; Full time

Job summary

Integra LifeSciences Corporation in Anasco, PR is seeking a Manufacturing Operator I for Collagen processes, including enzymatic and alkali treatments, tendon collagen prep, dispersion, and lyophilization. You will operate and clean clean room equipment in ISO Class 5/7 areas and follow GMP, SOPs, and Health and Safety requirements.

In a team environment, you will label materials, cut collagen sponges, inspect products for defects, and pack finished goods while maintaining documentation.

Qualifications

• High School diploma or equivalent.
• 0–2 years chemical processing experience in Medical Device or Pharmaceutical manufacturing.
• Production experience in a clean room environment desirable.
• Basic computer skills for email and data entry.
• Must read, write and speak English clearly.
• Understanding of mathematics and chemistry helpful.
• Able to participate in a team environment and train others.
• Able to work independently with minimal supervision.

Responsibilities

• Writes labels for materials, components and products with details.
• Cuts collagen sponges to specified sizes using cutting equipment.
• Inspects collagen products for defects and surface quality.
• Packs products as instructed and reads shop orders or procedures.
• Follows Clean Room Rules and Gowning Practices.
• Maintains clean and organized work area; assists peers as needed.
• Operates and troubleshoots process equipment and performs minor adjustments.
• Reads drawings and SOPs to ensure manufacturing specifications are met.

Skills

High School diploma or equivalent

0–2 years chemical processing

English communication

Basic computer skills

Gown to ISO Class 5/7

Teamwork and overtime readiness

Education

High School diploma or equivalent

Degree in related science a plus

Tools

Lyophilizers

Autoclave

Slicer machines

Sealing machines

Crosslinking chamber

Job description

## Manufacturing Operator I - CollagenApply: US-PR-Anasco-165-Facility: Full time: Posted Today: JR-6733Changing 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** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. * 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** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. * 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 perceptionSalary Pay Range:$10.50 - $13.46 USD HourlyOur 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.