What are the responsibilities and job description for the Qualification Engineer II position at Aequor?
Job Title: Qualification Engineer
Location: Davie, FL
Duration: 6 Months
Core Essential skill sets candidates must have:
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Location: Davie, FL
Duration: 6 Months
Core Essential skill sets candidates must have:
- Recent college graduated with 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
- Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs)
- Execute the trials and studies in coordination with planning, manufacturing, quality, engineering and PM groups.
- 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.
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.
