Sterile Fill Production Machine Operator (Midnights)

Why Us?

We want the best and brightest people 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

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.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

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

Job Description

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

Accountability

Responsibilities

% of Time

Operational

Sets-up, checks, adjusts and runs production equipment as required by product and size change over. This requires the PMO to bend, lift, use both hands and have correct 20/20 vision

Communicates effectively and on a timely basis to fill and seal operators

Coordinates with Area Supervisors to ensure an efficient filling operation

Communicates with Supervisor in a proactive manner with respect to line operating conditions, product quality status, and potential improvements

Cleans lubricates, starts, stops and services equipment necessary to promote and maintain a smooth & efficient flow of production

When necessary, performs required environmental and personnel monitoring sampling and recording

Determines and verifies that correct and adequate labels, materials and supplies have been provided to meet production schedules

Maintains a continuous supply of materials to production lines

Notifies Area Supervisor of processes or equipment not in a state of regulatory compliance when discovered

70%

Documentation

Documents all line clearance forms and other documentation forms necessary for the processing of each batch

Records downtime, production output and other manufacturing documents as assigned

10%

Compliance

Maintains eligibility for core qualification

10%

Testing

Integrity tests sterilizing filters

10%

Other

Performs other duties as assigned by Area Supervisor

Continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

High School Diploma, GED or equivalent

Successful completion of in-house training programs (includes Upgrader Exam)

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

Arithmetic Aptitude preferred

Pressure and Temperature Aptitude preferred

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

Mechanical Aptitude preferred

Hand Tools and Measuring Instruments Aptitude preferred

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Required to reach with hands and arms and frequently required to use hands to finger, handle or feel

Occasionally lift and/or move up to 50 pounds

Specific vision abilities required by this job include close vision

Frequently exposed to moving mechanical parts

Frequently exposed to toxic or caustic chemicals

The noise level is moderate

Work environment is a production/manufacturing environment

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

EEO Statement:

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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