Lead Process Technician II (B shift)

Fresenius Medical Care•Ogden, UT

12d

About The Position

Provide advanced technical direction for machine operation, process setup and control, and employee training. Assist the Supervisor by training employees, planning and directing work, troubleshooting issues, resolving problems, and serving as an interface between employees and the Supervisor. Identify improvement opportunities and keep production lines running efficiently and compliantly. Perform shift supervisory roles when the Supervisor is absent. Monitor department operations, including yields, reject trends, quality, and compliance, and follow and enforce department policies and procedures. Operate production equipment according to validated limits and established procedures; troubleshoot systems and equipment; conduct preventative maintenance, changeovers, alignments, and repairs; and ensure equipment meets validation requirements and remains in its designed condition. Analyze equipment reliability trends and work to improve mean time between failures and mean time to repair. Lead technical training and coaching, monitor employee performance, and provide additional training as needed. Maintain expertise in manufacturing processes, process set-points, validated limits, and equipment functionality. Serve as a subject matter expert in verifying system operation, line clears, operating parameters, and quality system functions on the BPR according to SOP. Support validations, communicate operating and employee issues to the Supervisor, make recommendations, and work autonomously on assignments requiring judgment and initiative. Maintain GMP standards, procedures, and housekeeping, and comply with company policies and applicable laws and regulations. Additional responsibilities may focus on one or more departments or locations as specified in an applicable addendum.

Requirements

High school diploma required.
6–8 years of related experience.
Forklift certification required; provided through onsite training.
Departmental Quality Inspection Certification required; provided through onsite training.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals, and to present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts including probability, statistical inference, and plane and solid geometry, and to apply fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, draw valid conclusions, and interpret technical instructions in mathematical or diagram form while dealing with abstract and concrete variables.
Knowledge of spreadsheet and word-processing software.
Must meet Fresenius' minimum vision requirements for product inspection.
Regular attendance is an essential function of the job.
Ability to perform the described physical duties, including standing and walking 12-hour shifts, handling equipment and materials, and wearing required personal protective equipment.

Nice To Haves

Technical certification or associate's degree strongly preferred.
Bachelor's degree preferred.

Responsibilities

Monitor department operations, including yields, reject trends, quality, and compliance; follow and enforce department policies and procedures.
Operate production equipment in accordance with department goals, validated limits, and established procedures.
Troubleshoot area systems and production equipment when deviations occur, correct problems, ensure systems and equipment operate as designed, and 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 and ensure equipment setup meets validation requirements.
Identify and repair or replace defective parts; clean, inspect, and lubricate equipment; and maintain systems and equipment in their designed base condition.
Lead technical training and coaching of employees; monitor employee performance and assist employees who need additional training.
Maintain knowledge of manufacturing processes, process set-points, validated limits, and functionality of each process section.
Verify area system operation, line clears, operating parameters, and quality system functions on the BPR according to SOP.
Notify the Supervisor of operating problems and employee issues, concerns, and performance, including individual employee strengths and weaknesses.
Assist with validations as needed.
Work autonomously on assignments requiring considerable judgment and initiative, understand the business and quality-system context of work, and recommend solutions.
Communicate effectively with stakeholders outside the department, including management.
Determine methods and procedures for new assignments and act as an informal team leader, assisting junior staff with support tasks requiring judgment and initiative.
Maintain and enforce current GMP standards and operating procedures throughout the shift.
Maintain and enforce housekeeping in the work area and plant.
Follow Fresenius policies and comply with the Code of Business Conduct, company policies and procedures, and applicable laws and regulations.
Escalate difficult or complex issues to the Supervisor when necessary.
Assist with projects assigned by the direct Supervisor and perform other duties as assigned.
Maintain regular attendance and a good attendance record.
Perform shift supervisory roles when the Supervisor is absent.