Production Operator (II/III) / Sr. Operator

About the role

The Manufacturing/Production Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs).

Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality.

Responsibilities

• Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc.
• Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.
• Executes written SOPs to ensure the purity of materials involved in the manufacturing process.
• Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.
• Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
• Cleans manufacturing equipment and facilities according to established SOPs.
• Executes machine changeovers from batch to batch.
• May sample batches for quality testing. Executes required in-process product quality checks and documents accurately.

Requirements

• High School Diploma or equivalent experience
• Minimum of 3-20 years of experience in Pharmaceuticals/Biotechnology/Clinical Research
• Knowledge of Good Manufacturing Practices (cGMP)
• Experience in Pharmaceutical Glatt, Compression and Pan coating
• Strong background in solid dose manufacturing specific to Compression OR Encapsulation OR Coating OR Wurster Coating
• Experience in Pharmaceutical Granulation and Blending experience a potential plus

Qualifications

• Level II Operator: HS diploma, GED or College Associate Degree, Minimum of 2-5 years of pharmaceutical manufacturing experience
• Level III Operator: HS Diploma, GED or College Associate Degree, Minimum of 5+ years of pharmaceutical manufacturing experience
• Forklift certification may be required for certain jobs

Skills

• Proficient in running machinery
• Proficient in (Master Clean/Surface clean) equipment cleaning
• Proficient in sampling batches
• Proficient in doing basic set-ups
• Ability to participate in Continuous Improvement projects
• Qualified in any of the following manufacturing processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Potent Compound

Benefits

Salary: USD 47000 – 76000

Pay

Full Time

Schedule

Must be able to stand for long periods of time (up to 12-hour shifts)