Sterile Fill Production Machine Operator (AFT)

Endo

  • Rochester, MI
  • Permanent
  • Full-time
  • 2 months ago
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 SummaryIn 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 DescriptionKey Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeOperational
  • 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
ContinuousTotal100%QualificationsEducation & ExperienceMinimal 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)
KnowledgeProficiency in a body of information required for the jobe.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Arithmetic Aptitude preferred
  • Pressure and Temperature Aptitude preferred
Skills&AbilitiesOften 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 RequirementsPhysical & 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
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.

Endo