Senior Manufacturing Engineer

Join our growing team at Aphena Pharma !!!

Description

• Provide direct technical support to Technical Services Operations and the Quality Unit in order to achieve the reliable and compliant manufacture of non-drug products medical devices and drug products.
• Provide direct technical support to achieve the reliable and compliant manufacture of non-drug products medical devices and drug products via the use of validated equipment and manufacturing processes work instructions and procedures.
• Responsible for generating and implementing protocols for the installation operational and performance qualification of filling/packaging and blending Equipment Utilities software validation in accordance with appropriate regulatory agency.
• Produce Validation Plans IQ/OQ/PQ Protocols URS test scripts and SOPs as required to meet 21 CFR Part 11 requirements GAMP among others.
• Prepare review and approve engineering and validations documents for blending and packaging equipment. Establish life-cycle plans for equipment and process. Perform process capabilities on equipment.
• Prepare review approve and provide technical support for preparation of relevant technical documents as required such as: change controls corrective and preventative actions deviation investigations manufacturing batch records and procedures.
• Investigate and resolve manufacturing issues that lead to production delays and technical issues with the product. Generate manufacturing from investigations from these activities.
• Successful application of root cause analysis and systematic problem solving.
• Work within or lead cross-functional teams in positive fashion to implement companys manufacturing objectives and deliver on business plan and quality objectives.
• Attend and participate in process team meetings for production issues resolution and process improvements.
• Coordinate the ordering of necessary materials not in our stock required to machine the scheduled parts.

• Develop and implement 5S for various blending filling and packaging work centers.

Requirements

• Must have a Bachelors degree in Manufacturing Engineering Mechanical Engineering or similar engineering field.
• Must have completed formal course(s)/training in Lean Six Sigma and 5S.
• Must have 3 years of experience (full-time or part-time experience acceptable) in Engineering positions performing/utilizing the following:
  • Experience within the pharmaceutical and/or biotech industries
  • Equipment design and GMP manufacturing in regulated environment
  • Blending technologies and filling/packaging operations
  • Experience in conducting root cause analysis using 5Why and Fishbone Diagram.
  • Experience in using Minitab to analyze risk in the equipment.
  • Solid understanding of ISO and cGMP regulations pertaining to equipment validation and technology transfer.
  • Utilizing experience with: Microsoft Excel Word Visio and PowerPoint; AutoCAD at an expert level; SolidWorks at an expert level; CREO; Solid Edge; Minitab; and Smartsheets.

• online ( or email resume and cover letter to Marcy Harrison HR Generalist ()