Sterile Fill Production Machine Operator (AFT)

Endo; Rochester (MN); On-site; USD 35,000 - 45,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Sterile Fill Production Machine Operator. This entry-level position involves operating production equipment, ensuring compliance with safety regulations, and maintaining production flow. Ideal candidates will have a high school diploma and mechanical aptitude. Join a dedicated team focused on delivering life-enhancing products.

Qualifications

• High School Diploma or equivalent required.
• Proficiency in FDA regulations and GMP/GLP/GCP preferred.

Responsibilities

• Sets up and runs production equipment.
• Documents line clearance forms and production data.
• Performs integrity tests on sterilizing filters.

Skills

Mechanical aptitude

Leadership

Negotiation

Calibration

Technical writing

Education

High School Diploma

GED

Job description

Sterile Fill Production Machine Operator (AFT)

1 day ago - Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration, and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

In accordance with Current Good Manufacturing Practices, Standard Operating Procedures (written and/or oral) instructions, and Safety Regulations, the Machine Operator is responsible for ensuring the continuity of complex operations required to maintain production.

Job Description

Key Accountabilities

Key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities and % of Time

• Operational: Sets-up, checks, adjusts, and runs production equipment as required by product and size change over. This requires physical ability to bend, lift, use both hands, and have correct 20/20 vision.
• Communicates effectively and promptly with fill and seal operators.
• Coordinates with Area Supervisors to ensure efficient filling operations.
• Proactively communicates with Supervisor regarding line conditions, product quality, and potential improvements.
• Cleans, lubricates, starts, stops, and services equipment to promote smooth production flow.
• Performs environmental and personnel monitoring sampling and recording as necessary.
• Verifies that correct labels, materials, and supplies are provided to meet production schedules.
• Maintains a continuous supply of materials to production lines.
• Notifies Area Supervisor of processes or equipment not in regulatory compliance.

70%

• Documentation: Documents all line clearance forms and other necessary documentation for each batch. Records downtime, production output, and other manufacturing data.

10%

• Compliance: Maintains eligibility for core qualification.

10%

• Testing: Performs integrity tests on sterilizing filters.

10%

• Other: Performs other duties as assigned by Area Supervisor.

Continuous

Total: 100%

Qualifications

Education & Experience

• High School Diploma, GED, or equivalent.
• Successful completion of in-house training programs (including Upgrader Exam).

Knowledge

Proficiency in knowledge areas such as FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six Sigma, etc. Preferred aptitude in arithmetic, pressure, and temperature.

Skills & Abilities

Mechanical aptitude preferred. Skills in handling hand tools and measuring instruments are advantageous. Leadership attributes include coaching, negotiation, calibration, and technical writing.

Physical Requirements

• Reaching with hands and arms, handling, and feeling.
• Occasionally lifting/moving up to 50 pounds.
• Close vision and exposure to moving mechanical parts, toxic chemicals, and moderate noise levels.

EEO Statement

Endo is committed to equal employment opportunity and creating an inclusive environment where all employees feel valued and respected, regardless of race, color, creed, religion, sex, gender identity, sexual orientation, national origin, genetics, disability, age, or veteran status.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Endo by 2x.

Additional Openings

PRODUCTION OPERATOR - 1ST, 2ND & 3RD SHIFTS AVAILABLE - IMMEDIATE OPENINGS!!

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.