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Technical Writer II

Fort Lauderdale, FL 33314

Posted: 09/25/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 586492 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 30-35/hr **salary will be commensurate with experience 

POSITION SUMMARY:

An engineering technical analyst/writer who implements, supports, and manages practices and projects that improve quality, reliability, and efficiency. The position blends a working knowledge of equipment, processes, and management systems with an understanding of lean concepts to drive quality investigations and corrective actions associated to equipment and process, aimed to drive standardization, simplification, and efficiency into the culture.

ESSENTIAL AREAS OF RESPONSIBILITY:
  • Carries out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
  • Demonstrates a complete knowledge of manufacturing processes and equipment.
  • Writes quality deviation reports and manages writes/edits change controls and CAPAs related to quality deviations and process improvements.
  • Develops and interprets equipment reliability metrics.
  • Leads problem solving / root cause analysis initiatives to eliminate defects and waste; leads implementation of subsequent preventive actions.
  • Trains technicians and mechanics on lean concepts, zero loss culture, ownership culture, and equipment operating principles relevant to job function.
  • Conducts and/or supports operator technical training.
  • Tracks results and reports on quantifiable goals and objectives.
  • Follows approved safety, health, and environmental policies and procedures.
  • Other projects and duties as assigned.

POSITION REQUIREMENTS:

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
  • 3-5 years of experience on pharmaceutical industry or regulated environment.
  • Experience writing quality investigations and CAPA execution associated to process equipment, facilities and utilities.
  • Understanding of pharmaceutical processes.
  • Experience with investigative tools and analyses such as RCA, FMEA, Ishikawa Fishbone Diagram, Pareto Chart, 5 Whys, Failure Mode and Effects Analysis (FMEA), Scatter Diagram, Affinity Diagram, Fault Tree Analysis (FTA), etc.
  • Experience on using Computerized Maintenance Management Systems to pull and analyze data related to equipment maintenance and calibration plans, scheduling and execution.
  • Six Sigma Green Belt a plus.
  • Operational Excellence a plus.
  • Strong Organizational and multi-tasking skills. Demonstrates the ability to informally lead in a team based culture and work comfortably across all personnel levels.
  • Understands manufacturing equipment, processes and technologies.
  • Reading and ability to interpret blueprints and schematics.
  • Ability to handle and manage multiple projects with minimal supervision.
  • Proficient in computer applications including MS Office.

Problem Solving:
  • Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
  • Perform and lead root cause analyses and quality investigations related to equipment and systems malfunctions.
  • Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
  • Normally provides general instruction on routine work and detailed instruction on new assignments to direct reports.
  • May be asked to recommend methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
  • N/A

PHYSICAL REQUIREMENTS:
  • Standing for extended periods of time at work station or equipment.
  • Walking to move short distances quickly and frequently.
  • Sitting for extended periods of time at work station or mobile equipment.
  • Repetitive Motions - frequent motions of the wrists, hands and/or fingers.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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