Senior Manufacturing Engineer

Job Location:

Liquid and Topicals Division, MD - Easton, MD 21601

Education Level: 4 Year Degree

Salary Range: $91,728.00 - $91,728.00

Job Shift: Any

Job Category:
Engineering

• 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 validation 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 company’s 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.

• Must have a Bachelor’s 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 with in 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 5
  
  Why 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;
  Solid Works at an expert level; CREO;
  Solid Edge;
  Minitab; and Smartsheets.