Sterilization Operations Lead - GMP & Training

Bausch+Lomb; Greenville (SC); On-site; USD 55,000 - 90,000; Full time

Job summary

Bausch + Lomb in Greenville, SC is seeking a Sterilization Subject Matter Expert to lead aseptic and non-sterile manufacturing area operations, audits, and training. The role emphasizes compliance with GMP, ISO, EHS and continuous improvement in safety, quality, and efficiency.

You will mentor staff, document activities, support investigations, and help maintain batch records while coordinating with QA, MQA, and production teams to meet schedules and quality goals.

Qualifications

• High School diploma required; AA/AS or technical degree preferred.
• At least 2+ years of leadership experience required.
• Able to work quickly and under pressure.
• Good documentation, computer, and math skills.
• Must be detail oriented and quality conscious.
• Good team oriented and excellent communication skills.
• Must be able to read, write, and speak English.
• Ability to work different shifts/weekends as needed to maintain the production schedule.

Responsibilities

• Sterilization Subject Matter Expert; audit support; liaison with MQA., Filling and Warehouse personnel.
• Performs technical training of personnel, mentor new associates.
• Cleans and disinfects aseptic and non-sterile manufacturing areas.
• Transfers material, equipment, and components into the aseptic area.
• Schedules and performs preventive maintenance activities.
• Reviews sterilization loads and cycle count acceptance. Supports recording dosimeter readings
• Properly document all activities and operations correctly and on time in the batch record/logbook.
• Assists Manager with scheduling and own logbook reviews and corrections
• Assist in the update of SOP revisions, processing logbooks and forms for Sterilization Department.
• Review, update and correct direct report’s timecards. Assist Manager and Group Leads with maintaining the Time Off calendar for the Sterilization Dept.
• Obtain CATSWeb access and launch and/or assist with: NCs, Investigations, and Internal Qualifications/Certifications.
• Supports Operations and QA investigations while interacting with internal technical resources and internal customers.
• Meets and maintains all required training during the year (SOP, EHS, and HR).
• Support operational excellence and EHS initiatives.
• Assume responsibility for the GMP, ISO, EHS awareness and compliance within the respective areas.
• Attend and participate in OpEx improvement initiatives such as reducing costs and OEE improvements.
• All other duties, as assigned.

Education

Internal Qualifications/Certifications: Aseptic Gowning

Internal Qualifications/Certifications: Disinfection

Internal Qualifications/Certifications: Irradiator License/Qualification

Internal Qualifications/Certifications: Train the Trainer

Internal Qualifications/Certifications: ITCRs

Internal Qualifications/Certifications: Kintana

Internal Qualifications/Certifications: D2

Job description

Bausch + Lomb in Greenville, SC is seeking a Sterilization Subject Matter Expert to lead aseptic and non-sterile manufacturing area operations, audits, and training. The role emphasizes compliance with GMP, ISO, EHS and continuous improvement in safety, quality, and efficiency.

You will mentor staff, document activities, support investigations, and help maintain batch records while coordinating with QA, MQA, and production teams to meet schedules and quality goals.