AVA Inc. Job Posting
Job Title:     Senior Pharmaceutical Engineer
Location:     Willowbrook, IL, US
Application Period Starts:   05.APR.2024
Application Period Ends:     05.MAY.2024

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 commercialscale 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:
  1. 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. 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;
  3. 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)?
  4. 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;
  5. Experience in a development and/or manufacturing support role for drug products and/or drug substances manufacturing;
  6. Experience with an FDA regulated environment and FDA regulations/cGMP standards.

Sign in to Google to save your progress. Learn more
Email *
1.    What is your desired start date? *
MM
/
DD
/
YYYY
2.    Are you currently authorized to work permanently in the United States? (I.e. Are you one of the following: a United States citizen; a Lawful Permanent Resident (“green card” holder); a Conditional Permanent Resident; a Temporary Permanent Resident; a Refugee; or an Asylee?) *
3.    Will you now or in the future require sponsorship for employment visa status (e.g. H-1B, H-4, L-1, L-2, TN, etc.)? *
4.    Are you subject to a written employment, non-compete, or non-solicitation agreement? *
5.    Would you accept this position for a based annual salary of $108,514.00 per year? *
6.    This position requires a Master of Science degree in Chemical Engineering, Pharmaceutical Engineering or a related field, or foreign equivalent and 2 years of experience in the pharmaceutical industry.
6.a.    Please confirm your educational background. *
6b.    How many years of relevant experience do you have? *
7.    Are you willing to supervise First-Line Supervisors of Production and Operating Workers? *
8.    Do you 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? *
9.    Do you have 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?
 *
10.    Do you have 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)? *
11.    Do you have 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? *
12.    Do you have Experience in a development and/or manufacturing support role for drug products and/or drug substances manufacturing? *
13.    Do you have Experience with an FDA regulated environment and FDA regulations/cGMP standards? *
How should AVA Inc. reach out to you regarding this application?
 *
Submit
Clear form
Never submit passwords through Google Forms.
This form was created inside of Bajaj Medical. Report Abuse
Google Forms