Production Operator Sr. Production Operator

Chantilly, VA - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Title: Production Operator II III (Compression Coating Granulation Encapsulation)

Location: Chantilly VA

Department: Production Operator II - III (Skilled Operators)- must have OSD Manufacturing experience

Job Summary

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. 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.

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.

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.

Skills required

Looking for candidates strictly from the Pharmaceuticals or Nutraceuticals industry only.
Experience with cleaning setting-up dismantling and operating state of the art tablet presses and encapsulation
Experience in 1 or more of the following areas: Compression (Tri-Layer Press) Granulation Encapsulation Ackley Laser Drill or Tablet Printing
Wurster Coating Coating Fluid Bed Dryers Bead Tower.
Must have Oral Solid Dosage Manufacturing experience
Knowledge of Good Manufacturing Practices (cGMP)
Basic English Communication (reading & speaking)
Current Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) and other regulatory requirements
Standard Operating Procedures for process rooms and manufacturing area
GMP compliance in a regulated work environment
Manufacturing processes and equipment procedures

Experience & Education

Level II Operator

HS diploma GED or College associate degree
Minimum of 2-5 years of pharmaceutical manufacturing experience and certification in assigned area as required or proficiency demonstrated in competencies as required.

Level III Operator:

HS Diploma GED or College associate degree
Minimum of 5 years of pharmaceutical manufacturing experience and certification in assigned area as required or proficiency demonstrated in competencies as required.
Strong background in solid dose manufacturing specific to Compression OR Encapsulation OR Coating OR Wurster Coating

Position Title: Production Operator II III (Compression Coating Granulation Encapsulation) Location: Chantilly VA Department: Production Operator II - III (Skilled Operators)- must have OSD Manufacturing experience Job Summary The Manufacturing/Production Operator performs functions relating ...