Role Summary
Manufacturing Technician II, Compounding, on a 6:00 AM–6:30 PM B1 shift (Thursday/Friday/Saturday and every other Wednesday). Responsible for compounding high-quality solutions, semi-solids, and suspensions in accordance with Good Manufacturing Practices (GMP) and department Standard Operating Procedures (SOP). Works in a controlled environment and supports production scheduling to ensure timely delivery of products.
Responsibilities
- Accurate formulation of products.
- Stage, load, operate, and monitor all equipment for product formulations.
- Weighing and mixing chemicals according to specific formulas.
- Calibrate, operate, and monitor all formulation-related equipment (e.g., mixers, scales, meters, etc.).
- Perform operations necessary to adjust the pH of product for in-process testing.
- Clean, steam, and sanitize all tanks, facilities, equipment and chemical containers used in the product formulation process in accordance with current SOPs and cGMPs.
- Accurately complete documents and record production volumes (batches) in compliance with current GDP standards.
- Assumes other duties and responsibilities, as necessary, within the Compounding department, to support adherence to the production schedule.
Qualifications
- Education - High School Diploma or GED equivalent. Associate’s Degree preferred with coursework in the Sciences.
- Experience - Bulk manufacturing or product manufacturing experience highly preferred.
- Technical - At least two (2) years related work experience, preferably in a high-speed production or manufacturing environment.
- Regulatory - Experience working in a GMP regulated environment preferred.
- Systems - Basic user knowledge of Microsoft Office; SAP experience preferred.
- Aseptic - Experience working in an Aseptic Production environment preferred.
Skills
- Ability to perform detailed tasks and document activities completely and accurately.
- Ability to think and plan in a logical sequential order.
- Able to work in a controlled environment that includes surgical mask and goggles.
- Ability to comply with gowning validation and subsequent gowning verifications.
- Ability to work any shift (up to 12 hours) as required dependent on business needs.
- Capable of standing for long periods of time; able to use hands to feel objects, use tools or controls, and reach with hands and arms.
- Ability to read, comprehend, write, and communicate effectively in English.
- Ability to carry out detailed written or oral instructions.
- Ability to work and communicate with others in a professional and effective manner in a team-oriented environment.
- Basic user knowledge of Windows-based computer systems such as Microsoft Office, with ability to learn other systems.
Education
- High School Diploma or GED equivalent. Associate’s Degree preferred with coursework in the Sciences.
- Experience with bulk/product manufacturing; GMP experience preferred.
Additional Requirements
- Physically able to continuously stand and walk.
- Physically able to lift up to 40 lbs.
- Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
- Ability to work any shift (up to 12 hours) as required by business needs.