Lead Sterile Manufacturing Operator

Position Summary
Duties And Responsibilities

  The Lead Sterile Manufacturing Operator (SMO) is responsible for overseeing, and
 executing where needed, all processes related to the manufacture of sterile product at
 Xseer’s 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211
 and USP / regulations, current Good Manufacturing Practices (cGMP), and
 department’s Standard Operating Procedures (SOPs).
  Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
 Manufactures sterile products accurately and in compliance with master batch records
 while adhering to department specific SOPs.
 Utilizes and coaches team on appropriate aseptic technique when performing tasks
 within the cleanroom.
 Operates all fill-finish and ancillary manufacturing equipment in order to deliver
 quality medication.
 Maintains an ISO classified environment through rigorous cleaning and disinfecting of
 the cleanroom in accordance with approved procedures.
 Adheres to, and completes, standard work documents, ensuring designated shift
 personnel understand and achieve daily target goals.
 Assists with sterilization of components used in the manufacturing process.
 Performs/reviews essential calculations and completes thorough documentation.
 Completes final review of cGMP documentation.
 Methodically prepares work area and supplies prior to manufacturing.
 Performs transfer of products from the cleanroom to the Inspection and Labeling team.
 Performs ancillary tasks and duties that support the manufacturing process such as, but
 not limited to, autoclaving, bubble point testing, material preparation, inventory
 accounting, organization of components, and various LEAN manufacturing tasks (6S,
 GEMBA, Kaizen).
 Assists Sterile Manufacturing Manager with task delegation and completing shift reports.
 Ensures all required hygienic practices and garbing are performed per company policy.
 Observes and aids in coaching new hires on sterile operations.
 Is dependable with attendance and is on-time for each shift start.
 Provides overtime leadership support, as needed, to maintain appropriate inventory
 levels.
 Assist with special projects, as needed.
 To perform this job successfully, an individual must be able to perform each essential
 function satisfactorily. The requirements listed above are representative of the knowledge,
 skill, and/or ability required. Reasonable accommodations may be made to enable qualified
 individuals with disabilities to perform the essential functions.
 While performing the responsibilities of the job, the employee is required to talk and hear.
 The employee is often required to remain in a stationary position for a significant amount of
 the workday and frequently use their hands and fingers to handle or feel in order to access,
 input, and retrieve information from the computer and other office productivity devices. The
 employee is regularly required to move about the office and around the corporate
 campus. The employee is occasionally required to stand, walk, reach with arms and hands,
 climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job

 Lead Sterile Manufacturing Operator
 include close vision. Employee must be able to stand and walk for extended periods of time
 for consecutive days. Employee must be able to lift up to 30 lbs.
 Knowledge And Skills
Must be trained and qualified in the sterile operation via internal training program.

Experience And Qualifications
  
  Must be Gown Qualified, permitting entry into the cleanroom.
 Detail-oriented and self-motivated.
 Work in a confined, controlled environment for extended periods of time (4 plus hours).
 Must be able to fully gown in aseptic garb for extended periods of time.
 Must be able to work with hazardous substances (drugs) and work with strong odors
 (such as, but not limited to, peracetic acid).
 Communicate and collaborate effectively with a team to achieve goals around safety,
 quality, and delivery.
 Ability to carry out and/or deliver detailed written and oral instructions.
 Must be able to perform rudimentary mathematical calculations.
 Key Competencies
 Customer Focus: Ability to build strong customer relationships and deliver customer
 centric solutions.
 Optimizes Work Processes: Know the most effective and efficient processes to get
 things done, with a focus on continuous improvement.
 Collaborates: Builds partnerships and works collaboratively with others to meet shared
 objectives.
 Resourcefulness: Secures and deploys resources effectively and efficiently.
 Manages Complexity: Makes sense of complex, high quality, and sometimes
 contradictory information to effectively solve problems.
 Ensures Accountability: Holds self and others accountable to meet commitments and
 objectives.
 Situational Adaptability: Adapts approach and demeanor in real time to match shifting
 demands of different situations.
 Communicates Effectively: Develops and delivers multi-mode communications that
 convey a clear understanding of the unique needs of different audiences.
  High School Diploma or equivalent required.
 Previous manufacturing experience required. 503B experience preferred.
 Experience with operation of equipment and/or tools required.

 Lead Sterile Manufacturing Operator
  Previous cGMP experience required; LEAN manufacturing experience preferred.