Stefanini Group
Quality Manufacturing Engineer
Stefanini Group, Davie, Florida, United States,
Details:
Stefanini Group is hiring!
Stefanini is looking for Quality Manufacturing Engineer for Davie, FL location (100% Onsite work).
For quick Apply, please reach out to Shubham Singh- call: 248 728 2629/email:shubham.singh@stefanini.com
Open for W2 candidates only!
100% Onsite position
Shift: Monday - Friday 8:00am - 5:00pm, 40 hours a week
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 notebooks 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. Job Requirements
Details:
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. Hands-on experience on equipment, facilities, and systems qualification. 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. 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.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group:
The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
Pay Range:
$ 45.00 - $ 45.00
Stefanini Group is hiring!
Stefanini is looking for Quality Manufacturing Engineer for Davie, FL location (100% Onsite work).
For quick Apply, please reach out to Shubham Singh- call: 248 728 2629/email:shubham.singh@stefanini.com
Open for W2 candidates only!
100% Onsite position
Shift: Monday - Friday 8:00am - 5:00pm, 40 hours a week
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 notebooks 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. Job Requirements
Details:
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. Hands-on experience on equipment, facilities, and systems qualification. 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. 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.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group:
The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
Pay Range:
$ 45.00 - $ 45.00