Position Description, Functions, Duties and Tasks:
Operate and maintain equipment and complete all required documentation under FDA and cGMP specifications.
Record information accurately and legibly per batch records and procedures.
Troubleshoot equipment or conditions, make recommendations to the Process Engineers, Maintenance Engineer, or Group Leader, and implement changes to achieve efficient operating conditions.
Perform area Preventive Maintenance (PM’s) and Work Orders (WO’s) on equipment in Plant Utilities and Clean Utilities departments and record time worked against work orders in SAP tracking system.
Develop and revise SOPs. Train and develop other Operators.
Perform in-process analysis including, but not limited to, pH, conductivity, spectrophotometry and titration.
Monitor the Console control board, investigate alarms, and make required adjustments.
Perform housekeeping to keep the area clean and free of hazards.
Perform in a team-based environment, willing to participate in team activities, serve in leadership roles, and be receptive to receiving and giving constructive coaching to team members and management.