Qualification Engineer in Davie, FL

100% Onsite position

Shift: Monday - Friday 8:00am - 5:00pm

Core Essential skill sets candidates must have:

• • Recent college graduated with Engineering (Mechanical, Electrical, Chemical, Civil, Industrial or Computer) Master’s or higher degree
  • Must have a minimum of 3 months relevant experience
  • Must have worked in a Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development program
  • Minimum knowledge on engineering/facilities/equipment/utilities applications and qualification such as HVAC, DC, Compressed Air, Pharmaceutical equipment

Job Summary:

• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) .
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing equipment, utilities and facilities. Coordinate activities with various departments and prepare technical reports.
• Performing periodic reviews, statistical assessments, trend analysis and generate leading and lagging KPIs.
• Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs)
• Provide Technical assessments/ product impact assessment summaries on time
• Execute the trials and studies in coordination with planning, manufacturing, quality, engineering and PM groups.
• Review and analysis of the process, analytical and statistical data to support the qualification and validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.
• Identify and coordinate the equipment requirements with R & D, Engineering, Employee Health and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for the commercial scale pre-validation development/ scale up of the ANDA lots.
• Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.
• Remediation of the audit related observations (if any) and timely completion of the action items (if any)
• Maintenance of appropriate documentation of protocols, reports and laboratory note books as required by Standard Operating Procedures (SOPs) and internal policies.
• Lead process and equipment automation and modernization projects, creating automated trending and dashboards
• Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
• Leading multiple new technology introduction, upgrades and automation.
• Responsible for performing additional related 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:

• Requires a college fresh Ph.D. or Master’s degree with a minimum of 3 months relevant experience in the field of pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation in chemistry or chemical engineering or related field.

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