Operations Equipment Specialist

Pharmaceutical Associates, Inc Greenville , SC 29617

Posted 2 weeks ago

Job Summary:

The Operations Packaging Specialist Lead will lead and be responsible for providing support to the Packaging department to ensure that technical skills and training are developed among the Packaging team, and Packaging technical challenges are addressed. This role will also apply to the operation of machinery and complete improvement projects in alignment with Site's Strategic Plan.

Responsibilities:

The Operations Packaging Specialist Lead will not have direct reports but will work closely with Learning & Development group, Shift Supervisors and Operators to identify and address skills development opportunities within the packaging team.

Duties:

This position is considered full time, 40-hour per week on average, position on a daily basis. Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions.

Training

  • Develop training materials and standard work documents to ensure consistent execution amongst all packaging teams.

  • Complete training for packaging personnel ensuring details of what to do and why is included.

  • Partner with Shift supervisors to assess training opportunities for employees and create development plans.

  • Provide regular trainee progress reports and status updates.

  • Utilizes "Prep-Show-Do-Check" training method for instruction.

  • Support revision or creation of SOPs, WIs, Job Aids and training materials.

  • Work closely in conjunction with and as part of the Learning & Development group for training guidelines, techniques, methods, and best practices.

Improvement process

  • Capture opportunities observed and resolve them with corresponding team members.

  • Track performance after implementation to determine effectiveness and perform further adjustment as necessary.

  • Continuously share lessons learned with Operations personnel related to documentation, transactions, changeovers, etc.

  • Present management updates on progress and action plans.

  • Optimize changeover process and train employees on related documents and lessons learned.

Execution (Daily) Process

  • Answer questions, provide directions. Ensures trainee gains full understanding and correctly demonstrates processes prior to release.

  • Champion all cGMP/GDP standards.

  • Maintain daily vigilance on packaging line operation to identify deficient processes, procedure, or personnel skills and recommend actions to be taken with supervisors.

  • Maintains communication with other departments on key issues.

  • Perform troubleshooting and diagnose complex filling and packaging equipment / systems.

  • Review batch record prior to production start. Ensures required documentation is entered into batch record accurately.

  • Changeover and set up process Main coordination. This includes readiness of all inputs beforehand, monitoring the changeover process to ensure optimization of resources, parts, and communication between functional areas.

  • Monitors equipment throughout production ensuring proper operation.

New Products / Processes

  • Operations Liaison with Technical Services, Project Management and Packaging Department for Commercial, Noncommercial, Experimental, and Exhibit runs.

  • Provide technical input on the equipment and workstation layout design, develop factory and site acceptance tests, execute IOPQ testing.

Required Skills/Abilities:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Team Building

  • Effective communication skills

  • Competent in troubleshooting equipment / process and product related issues.

  • Ability to influence non direct reports / peers to accomplish objectives during production and changeover.

  • Interfaces with Quality and Supervisors to inform of deviations or other line issues.

  • Working in partnership with the Supervisor, coordinate Packaging assignment during each shift.

  • Positive attitude/enthusiasm toward training others

  • Good attendance record

  • Ability to flex to learn new processes based on business need.

Education and Experience:

High school and/or on the job education in a specific skill area, E.G. data processing, clerical/administrative, equipment operation, etc., plus 2 years related experience and/or training, and or equivalent combination of education and experience.

Certified Train the Trainer

Physical Requirements:

Prolonged periods of standing. Kneeling and climbing ladders will be required.

Must be able to lift up to 50 pounds.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled


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