at AVA Inc. in Willowbrook, Illinois, United States
Job Description
Job Title: Senior Pharmaceutical Engineer
Job location –Willowbrook, IL
Responsibilities:
- Monitor Quality Control analytical testing of raw materials, in-process and finished pharmaceutical OTC and generic drug products including review and approval of data analyses from processes and experiments;
- Perform laboratory studies of steps in manufacture of new drug products and/or drug substances and test proposed processes in pilot-scale and commercial scale operations;
- Develop, revise and/or approve standard operating procedures;
- Utilize experience to train quality department personnel to drive quality awareness;
- Initiate change controls for documents, equipment and processes;
- Support validation through preparation of design documents and protocol review;
- Apply regulatory expertise to identify and analyze potential trends upon review of customer complaints, investigations, nonconformances, and stability studies data;
- Identify and recommend Corrective and Preventative Actions (CAPAs) to resolve trending issues, nonconformances, and complaints;
- Utilize engineering knowledge and skills to facilitate process design and product development for manufacturing of drug products and/or drug substances;
- Assist in conception, design, and scale-up of manufacturing and packaging processes;
- Determine most effective arrangement of operations such as mixing, heat transfer, cooling, filtration, etc.
- Evaluate drug product and/or drug substance equipment and processes to identify ways to optimize performance or to ensure compliance with safety and environmental regulations;
- Direct activities of workers who operate or are engaged in production, packaging and quality control activities;
- Implement regulatory proficiency to perform internal audits in compliance with 21 CFR, cGMP and FDA guidelines;
- Perform Annual Reporting and Review activities for drug products and/or drug substances associated with USFDA NDA/ANDA & DMF applications, Health Canada NDS/ANDS & ASMF applications and/or EU CEP applications;
- Create and/or review, publish and submit regulatory filings for NDAs, ANDAs, INDs, DMFs, annual reports, and periodic safety reports, per commitments made with the FDA, Health Canada and/or EDQM in eCTD schema;
- Implement FDA regulations, validation assurance, quality control and maintain Good Manufacturing Practices (GMP) compliant facility;
- Responsible for maintenance of product quality and environmental safety, adhering to the quality system and cGMP.
- Supervise First-Line Supervisors of Production and Operating Workers.
Requirements:
Master of Science degree in Chemical Engineering, Pharmaceutical Engineering or related field, or foreign equivalent and 2 years of experience in the pharmaceutical industry.
The position also requires:
- 2 years of regulatory experience in performing tasks in compliance with 21 CFR (specifically §21 CFR 201, 210, 211, 314) and/or of regulatory agencies such as the FDA, Health Canada, EDQM and/or OSHA with awareness of cGMP, GxP (GDP, GLP), ICH Q7, Q8, Q9 guidance;
- 2 years of operating and troubleshooting experience for equipment such as pH meter, analytical balance, viscometer, GC, HPLC, FTIR, UV-Vis Spectrophotometer, Mass Flow Meter, RO Filtration, TOC meter, UV and Flow Sensors;
- 2 years of work experience in utilizing eCTD Publishing and Validating applications such as KnowledgeNET and/or Lorenz eValidator; statistical Quality Analysis applications such as MiniTab; Microsoft Office (Word, Excel, PowerPoint, Publisher and/or Access);
- 2 years of experience in utilizing Chemical process Design & simulation software such as ChemDraw, Chemstations (ChemCAD), Autodesk, Aspen HYSYS, Simulink, MicroStation, StackBuilder, SCADA and financial analysis and/or accounting software such as Quickbooks;
- Experience in a development and/or manufacturing support role for drug products and/or drug substances manufacturing;
- Experience with an FDA regulated environment and FDA regulations/cGMP standards.
Any applicant who is interested in this position may send a resume to arjun@bajajmedical.com or apply through the company website, www.avapharma.com; ref job# Senior Pharmaceutical Engineer.
