Senior Manufacturing Engineer
About The Position
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 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.
Requirements
- 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 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.
Responsibilities
- 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.
- Generate and implement 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.
- Apply 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
