Job Description
Stefanini Group is hiring!
Stefanini is looking for
Process Engineer
for
Davie, FL Location
For quick Apply, please reach out to Arjun Raj Sharma - call:
248-728-2618
mail:
arjun.rajsharma@stefanini.com
Work Hours: M-F (40 hours)
Work Location - Davie, FL
Shift: 1st Shift
Summary:
- This position is responsible for performing activities related to critical aspects of products and processes, including process development, pre-validation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including validation.
- Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing and planning. Maintains of expertise related to formulation, raw material properties and manufacturing processes.
- Identifies, analyzes and suggests corrective actions to optimize procedures, processes, materials, technology and regulatory compliance issues. Provides direction and training to other staff, technicians and manufacturing operators.
Essential Areas of Responsibility:
- Work with limited guidance from supervisor or seniors to drive projects to completion.
- Providing process-engineering expertise for technology transfer, from pre-validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.
- Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
- Design, develop and optimize process simulation techniques for process optimization and scale up.
- Partner with internal and external groups to ensure technical success of technology transfer and continued cost effective manufacturing; provide continued technical leadership to commercial operations for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies.
- Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.
- Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.
- The incumbent is responsible to ensure compliance with all laws, regulations, codes, standards and company policies relevant to this position.
- Provide process expertise, create and update MBR and support batch record review and analysis.
- Act as a quality events investigator for assigned projects.
- Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
- Perform studies to support necessary equipment and system PQ's and PPQs to assure compliance in all manufacturing and support areas, analyze data using appropriate statistical tools.
- Maintain product during lifecycle (stage 3 - CPV) using appropriate statistical tools.
- Use appropriate project management tools; provide timely updates to management on the status of various projects.
- Implement and use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion - spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
- Execute material changes, process changes, and cost reduction projects.
- Provide technical training and assistance to others.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- 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), and Standard Operating Procedures (SOP's) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
Education/Certification/Experience:
- Requires a bachelor's degree pharmacy, engineering or science with a minimum of 4 years' relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation OR related field.
- Advanced degree is preferred.
- A combination of education and experience will be considered.
Skills/Knowledge/Abilities:
- Understanding of various unit operations used in conventional and novel oral solid dosage manufacturing.
- Comply with FDA regulations at all times.
- Business, scientific and personal computer hardware and software applications.
- Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
- Must be able to maintain the highest levels of confidentiality, integrity and discretion.
- Excellent verbal, written, and interpersonal skills required.
***Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.