Under direct supervision, perform equipment preparation, autoclaving, filling, stoppering, labeling, inspecting and packaging of products in the aseptic (sterile) environment. Maintains aseptic manufacturing environment through cleaning and sanitization of equipment, ceilings, walls and floors. Produces pharmaceutical components and products by setting-up, cleaning, operating, and maintaining equipment; following aseptic procedures; documenting actions.
Essential Functions and Primary Responsibilities
Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies.
Prepares equipment by performing sterile cleaning-in-place (CIP), servicing-in-place (SIP), and cleaning out-of-place (COP); conducting operator inspections; performing preventive maintenance checks
Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
Documents production by completing forms, reports, logs, and records of equipment and batches.
Updates job knowledge by participating in training opportunities.
Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
High School diploma or equivalent required.
Experience in pharmaceutical manufacturing or related industry required.
Qualification to gown and work in the Aseptic area required.
Basic Knowledge of cGMPs.
Effective communication skills with the ability to work on a team.
Solid arithmetic and writing skills used to record data and equipment settings.
Knowledge, Skills and Abilities
Equipment Calibration, GCP, Manufacturing Methods and Procedures, Manufacturing Quality, Production Planning, Tooling, Pharmacology, Attention to Detail, Thoroughness, Documentation Skills, Analyzing Information. Good knowledge and understanding of quality control, SOPs, cGMPs, OSHA, FDA policies and regulations, personnel policies, and budget guidelines.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; balance; stoop, kneel, crouch or crawl; talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus. The employee is exposed to outside weather conditions.