Operador de Producción Farmaceutica

The 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. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.

992169

*English communication required*

Key Accountabilities:

• 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.
• Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward.

Documentation:

• Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
• Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.
• Verifies the manufacturing process on BPR in an accurate and timely manner.
• Provides status updates and operational challenges on status boards.

Continuous Improvement:

• Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor.
• Typically participates in at least one continuous improvement project of a moderate scope and complexity.

Safety & Compliance:

• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participates in safety teams, start-up discussions, incident debriefing sessions, etc.
• Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
• Maintain a clean, organized, work area.

Training:

• Conforms to all training requirements, including company required and machine-specific training.

Teamwork & Collaboration:

• Contributes to team and project success by sharing previously acquired knowledge.
• Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.

Requirements

- Trainee - Level I Operator:

• HS diploma, GED or College Associate Degree
• Minimum of 1-3 years experience in a labor intensive environment
• Forklift certification preferred.
• Ability to communicate and comprehend English language both verbally and written

- Level II Operator (OSD/Solid Dose Manufacturing experience required):

• HS diploma, GED or College Associate Degree
• Minimum of 3-7 years of OSD pharmaceutical manufacturing (cGMP) experience
• Forklift certification preferred.

- Level III Operator (OSD/Solid Dose Manufacturing experience required):

• HS Diploma, GED or College Associate Degree
• Minimum 7+ years of pharmaceutical manufacturing (cGMP) experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.
• Forklift certification preferred.

Required Knowledge & Skills for Level II & III

• Strong background in solid dose manufacturing (OSD)
• Experience in 1 or more of the following areas: Compression, Granulation, Encapsulation, Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower
• Capable of cleaning, setting-up, dismantling and operating state of the art tablet presses and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta; Korsch XM 12.
• Knowledgeable of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.
• Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.
• Basic math, reading, legible writing skills, and problem-solving abilities.
• Proficient in sampling batches
• Ability to participate in Continuous Improvement projects.

Required for all levels:

Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

Physical Requirements:

Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.

Additional information:

• Share resume exclusively in English
• Share your role of experience: Operator Level I, Level II, Level III