PURPOSE AND SCOPE:

Provide advanced technical direction in relation to machine operation, process setup and control and employee training. Responsibilities include training employees; planning, assigning, and directing work; troubleshooting issues and resolving problems and interfacing between employees and supervisor. Identify areas for improvement. Keep the production lines running in an efficient and compliant manner. Perform all shift supervisory roles in the event of the Manager’s absence.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Plans and directs production activities and establishes production priorities for products in keeping with effective operations and cost factors.
• Monitor all department operations including yields, reject trends, quality and compliance. Follow and enforce all department policy and procedures.
• Operate production equipment, in support of department goals, in accordance with validated limits and established procedures.
• Troubleshoot area systems and production equipment as deviations occur. Correct problems and ensure systems and equipment are operating as designed. Write work orders as needed.
• Organize and perform preventative maintenance on equipment.
• Analyze trends and improve equipment mean time between failure (MTBF) and mean time to repair (MTTR).
• Perform equipment changeover and alignment tasks. Ensure equipment setup meets all validation requirements.
• Identify and repair/replace defective parts. Clean, inspect and lubricate equipment. Ensure systems and equipment are maintained at their designed base condition.
• Lead in the technical training and coaching of employees.
• Responsible for PLC, servo, and robotic functionality and troubleshooting.
• Maintain a high level of training and understanding of the manufacturing process including process set-points, validated limits, and functionality of each section of the process.
• Acts as a subject matter expert in the verification of area system operation, line clears, operating parameters and quality system functions on the BPR as per SOP.
• Monitor individual employee performance and assists employees needing additional training.
• Notify Line Manager of general operating problems as well as employee issues, concerns and performance by advising supervisor of individual employee strengths and weaknesses.
• Assist as needed with validations.

• Works autonomously on assignments requiring considerable judgment and initiative. Understands business and quality system context and implications of work. Makes recommendations for solutions.
• Ability to communicate effectively with stakeholders outside of the department, to include management.
• Determines methods and procedures on new assignments.
• Act as an informal team leader and provides assistance to junior level staff with support tasks that require considerable judgment and initiative.
• Maintain and enforce current GMP standards and operation procedures throughout the shift.
• Maintain and enforce general housekeeping of working area and plant.
• Regular attendance and maintaining a good attendance record is an essential function of the job.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• May escalate difficult/complex issues to manager for resolution, as deemed necessary.
• Assist with various projects as assigned by direct manager.
• 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 and fingers, handle or feel; reach with hands and arms; talk or hear and wear personal protective equipment that may include hearing protection, hair net, smock, chemical resistant suit, chemical respirator, chemical resistant gloves, or cut gloves The employee is frequently required to stand and walk 12 hours shifts. The employee is occasionally required to sit; climb or balance and stoop, kneel, or crouch. The employee must regularly lift and/or move 10 to 25 pounds, frequently lift and/or move up to 50 pounds. For Solutions/Saline employees (as applicable), may occasionally lift and/or move more than 100 pounds with assistance.
• While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The noise level in the work environment is usually loud.

SUPERVISION:

• None

EDUCATION:

• High School Diploma required; Technical Certification or Associate’s Degree strongly preferred; and Bachelor’s Degree is preferred

EXPERIENCE AND REQUIRED SKILLS:

• 6 – 8 years’ related experience.
• Forklift Certification required and provided through onsite training
• Departmental Quality Inspection Certification required and provided through onsite training
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software.
• 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.