PURPOSE AND SCOPE:
The Sterilizer Operator will complete all performance steps for sterilization process as outlined in the SOP's and in accordance with cGMP. The Sterilizer Operator will account for all products in sterile and non-sterile areas from the time it is received from the Fill room to the time it is released to Packout.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Under limited supervision, applies considerable (insert) knowledge to perform a broad range of tasks which include but are not limited to training employees; planning, assigning, and directing work; resolving problems and interfacing between employees and supervisor. Keep sterilization running in an efficient and compliant manner.
- Works on assignments that are moderately difficult, requiring judgment in resolving issues and/or in making recommendations.
- Coordination of cart loading operations and personnel for cart identification, bag count and loading pattern verification.
- Coordinate with department personnel on lot related issues.
- Stage Sterilizer Carts.
- Operate automated cart loader
- Start and monitor sterilizer cycle.
- Perform various sampling procedures.
- Plan sterilization schedule to avoid exceeding expiration times.
- Coordination with Production Coordinator on container counts and other lot related issues.
- Provide Technical direction in relation to the Sterilization area.
- Contacts are frequently with individuals representing other departments, and/or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of a sensitive nature.
- Normally receives no instruction on routine daily work, and general instructions on newly introduced assignments.
- May provide assistance to junior level staff with more complex support tasks that require a higher level of understanding of functions, as directed by immediate supervisor.
- May escalate issues to supervisor for resolution, as deemed necessary.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Assist with various projects as assigned by direct supervisor.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and personal protective equipment required may include: safety shoes, hearing protection, bunny suit (Solutions). The employee is frequently required to stand and walk. The employee is occasionally required to climb or balance and stoop, kneel, or crouch. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds with extensive pushing, turning and pulling heavy carts.
- While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; extreme heat; risk of electrical shock and vibration. The noise level in the work environment is usually loud.
EDUCATION:
- High School Diploma required; Associate's Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
- 2 - 4 years' related experience.
- Must be able to meet Fresenius' minimum vision requirements for product inspection.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.