Manufacturing Operator IIIThe Manufacturing Operator III 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). This is a Lead role, is considered a process expert, and is a Certified Trainer of other Operators. This role supervises the day-to-day activities of the Operators and provides guidance on tasks that are being performed on the line. Often, this position is involved in the Operator interview process but are not decision makers in terms of hiring decisions, promotions, annual evaluations, etc. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize process issues and to increase efficiency, throughput, and quality. Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options. Troubleshoots process issues, analyzes root causes, and makes recommendations. 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. Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Responsible for the safe and efficient execution of job duties. May serve as back-up to the Senior Manufacturing Technician.
Essential Functions:
Manufacturing Process A depth of knowledge in fluid bed dryer operations is required to be able to operate and troubleshoot fluid bed dryer operations. Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOP's. Executes written SOP's 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 SOP'sExamines 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 SOPsExecutes machine change-overs from batch to batch Completes a variety of assignments independently based on established procedures Identifies process improvements that drive increased efficiency, throughput and quality Samples batches, including validation batches, for quality testing Executes required in-process product quality checks and documents accurately With Master Clean/Surface Clean certification, releases room to be master and/or surface cleaned 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 DocumentationCompletes documentation associated with manufacturing processes (e.g. batch record 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 Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Typically participates in Continuous Improvement projects of a higher scope & complexity Safety and Compliance Carries out processing/manufacturing activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participates in safety teams, start-up discussions, incident debriefs, etc. Ensures compliance with SOPs, Policies and Procedures as required by Company and regulatory agencies Maintains a clean, organized work area.
Training:
Conforms to all training requirements, including company required and machine specific training. May become a certified trainer and provide mentoring and training.
Teamwork and Collaboration:
Exhibits teamwork and motivates others to achieve project objectives. Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.
Qualifications
Education & Experience:
HS diploma with 5 years' Pharmaceutical Manufacturing Operator experience & certification in assigned area, as required Forklift certification is required for certain jobs.
Knowledge & Skills:- Knowledge of cGMPsBasic math, writing skills, and problem-solving abilities
- Has a wide range of technical skills and operational knowledge
- Understands the practical applications to problems and situations ordinarily encountered
- Proficiency in operating Fluid Bed Dryers or equivalent.
- Proficient in (Master Clean/Surface clean) equipment
- Proficient in setting up machinery
- Proficient in trouble shooting
- Ability to become a certified trainer and provide certified training in one process
- Ability to effectively interface with other departments if senior level (4th level) isn't available
- Ability to participate in Continuous Improvement projects
- Qualified in both Weighing or Blending (where applicable) and at least in 1 of the following manufacturing processes:
Granulation
CompressionCoatingEncapsulationPotent Compound
Safety and Security Observes safety and security procedures. Determines appropriate action beyond guidelines. Reports potentially unsafe conditions. Uses equipment and materials properly.
Physical Requirements:- Must be able to stand for long periods of time (up to 12 hour shifts), lift 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.
- Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects
- Vision - ability to see details at close range (within a few feet of the observer)
- Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness
- Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
