Manufacturing Engineer​/Quality Engineer

Manufacturing Engineer / Quality Engineer

Location:

North Chicago, IL 60064 Duration: 6 Months

Essential Job Functions:

• Participates and leads technology transfers from R&D to manufacturing sites or from one manufacturing site to another with cross functional team comprising Science & Technology, Manufacturing and Quality Assurance.
• Strong knowledge in aseptic processing and sterile product manufacturing.
• Participates in cross functional investigations to find resolution in timely manner, implementation of CAPAs
• Knowledge and experience with Design Control principles and requirements for drug-device combination products.
• Provides support to manufacturing sites for process validation, process improvement/optimization and process troubleshooting.
• Provides technical support including drafting and reviewing of documents/reports pertaining to technology transfer, new supplier qualification, process optimization, design control, etc.
• Participates in Science & Technology team meetings in order to standardize procedures for technology transfer and validation across all sites.
• Provides technical support for analysis of data using statistical tools such as JMP, Minitab or other equivalent.
• Provides timely updates to management on the status of various projects.
• Carries out responsibilities in accordance with the organization’s policies, procedures and state, federal and local laws.
• Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.

Required Knowledge and Skills:

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, EPA, DEA and other regulatory requirements.
• Prior knowledge and experience with aseptic processing and sterile products manufacturing.
• Understanding of regulatory requirements, ICH guidelines and different guidance documents.
• Pharmaceutical manufacturing principles, for parenterals and/or other sterile products, semi-solids, etc.
• Understanding of analytical test methodology (HPLC assays, GC, LC-MS, TLC, dissolution profile, etc.)
• Understanding of concepts of UV-VIS, HPLC, GC, TLC, DSC/TGA, X-ray etc.
• Understanding concepts of equipment, facility and utilities qualification/calibration.
• Pharmaceutical raw material tests (BD, TD, PSA, LOD, etc.) and raw material characterization.
• Intermediate statistical computations (process capability, stability analysis and prediction, etc.) and use of statistical software.
• Process improvement and scale-up for sterile products.
• Process/cleaning validation and technical transfer concepts.
• Project management principles.
• Annual Product Review Report (APRR).
• English usage, spelling, grammar and punctuation.
• Personal computer operations and Microsoft applications (Word, Access, Excel, PowerPoint, MS Project).

Skill in:

• Analyzing problems, identifying solutions and supporting implementation for resolution of the issue via CAPAs.
• Good technical writing skills for complex reports and regulatory documents.
• Ability to prepare all types of pharmaceutical documentation (batch records, BOMs, change controls, protocols, summary reports, evaluation reports).
• Strong technical skills and ability to influence team to make decisions, maintain open communication channels, present findings and technical challenges/resolutions to cross functional teams.
• Ability to handle multiple projects, duties and assignments.
• Ability to guide a team as well as work and contribute in a team environment.
• Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining good relationships with those encountered in the course of work.
• Operating a personal computer.

Top 3-5 skills:

• BS or MS or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field)
• 5-7 years' of technical experience in Process/Manufacturing/Project Engineering or similar role.
• Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing).
• Effective verbal and written communication skills in both English.
• Strong data analysis skills and experience (will be doing a lot of data mining)