Qualification Engineer

Compunnel
US - Florida - Boynton Beach
November 12, 2024
Engineering

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.

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.

Read the full job description and apply online on the recuiter's web-site

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