Batch Records Engineer Jobs (NOW HIRING)

Batch Maker II is responsible for leading a team of compounders and overseeing compounding daily activities.  Batch Maker II will ensure company policy is followed and that quality and production goals are met.  Batch Maker II will communicate with management and the compounding team.

Qualification Requirements

• High School Diploma or equivalent
• Associate degree in Manufacturing Technology, Industrial Technology, Engineering Technology, Chemistry, or related field preferred
• Strong organizational and communication skills
• 3-5 years of experience in cosmetics, personal care, pharmaceutical, food, or chemical batch manufacturing preferred
• Experience compounding liquid, cream, lotion, gel, or emulsion products preferred
• Experience working in a cGMP-regulated manufacturing environment
• Experience using industrial mixing, pumping, heating, and transfer equipment
• Knowledge of FDA rules and regulations is a plus
• cGMP and ISO experience is preferred
• Ability to lift up to 50 pounds
• Strong team building skills
• Proficient in basic math and computer skills
• Ability to thrive in a fast paced, high stress manufacturing environment
• Basic knowledge of industrial fork trucks is a plus

Minimum Qualifications (Must have/non-negotiable)

• High School Diploma or equivalent is required
• Basic understanding of cGMP is required
• Ability to read and interpret batch records and all company documents
• Proficient in basic math and computer skills
• Has experience leading a small group of team members

Knowledge, Skills and Abilities

• Proficient in basic computer skills and understanding of spreadsheets
• Proficient in addition, subtraction, and percentiles
• Technical Competencies
  • Serves as the technical leader for the Compounding department during assigned shift and provides direction to Batch Maker I employees
  • Identifies opportunities to improve safety, quality, efficiency, equipment reliability, and batch consistency
  • Ability to read, interpret, and execute Master Manufacturing Instruction (MMIs) and Batch Production Records (BPRs)
  • Experience operating mixing vessels, heated kettles, emulsifiers, pumps, transfer systems, and associated production equipment
  • Working knowledge of cGMP, GDP, ALCOA+, and ISO 22716 principles
  • Ability to recognize abnormal batch conditions and initiate appropriate escalation
  • Understanding of cleaning and sanitation requirements for cosmetic manufacturing equipment
  • Ability to troubleshoot common processing issues such a viscosity, pH, temperature, mixing, and transfer problems

Supervisory Responsibilities - Provides day-to-day work direction, training, coaching, and technical guidance to approximately three to five Batch Maker I employees.  Personnel actions such as hiring, discipline, performance evaluations, and scheduling remain the responsibility of the Compounding Supervisor.

Essential Functions

• Responsible to coach and mentor team members
• Ensures all company policy, safety, quality, and production procedure are adhered to 
• Processes daily batch records
• Performs batching when required
• Leads execution of daily batch manufacturing activities in accordance with the production schedule
• Reviews batch documentation before compounding begins
• Verifies raw materials, equipment readiness, and line clearance
• Coordinates Batch Maker I assignments to maximize efficiency
• Performs complex batch manufacturing requiring advanced technical knowledge
• Monitors batch parameters including temperature and mixing time
• Troubleshoots processing issues and escalates when necessary
• Assists with batch investigations, deviations, and corrective actions
• Ensures all documentation is complete, accurate, and compliant with cGMP requirements
• Trains and mentors Batch Maker I employees in safe and compliant manufacturing practices
• Coordinates with Quality, Warehouse, Maintenance, and Production to ensure efficient batch execution
• All other duties as direct by management

Physical Demands

• Ability to lift up to 50 pounds
• Sitting/Standing for long periods of time

Work Environment

• Climate controlled environment but could be exposed to weather conditions if needed