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SalaryPharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion, and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Packaging Engineer to join our team.
Job Summary:
The Packaging Engineer will help with the installation and validation (IQ/PVS/OQ/PQ) of several off-the-shelf packaging pieces of equipment for CNS and CPK including: Sterile tray infrared packaging inspection system implementation and validation. Support new material experimentation. Support early ship testing checks. Support early aging checks Tray/lid design for Form-Fill-Seal, Alloyd, and offload – including tolerances and process alignment (Tyvek repeat checks and such for the FFS). Support design and development phase for custom FFS with automation vendor. Support Form Fill Seal Machine(FFS) Validation (IQ/OQ/PQ). Design fixtures and create drawings in CAD software (i.e. SolidWorks) to support Production with their day-to-day operations. Help with Color-printing label operation.
Key Responsibilities:
- Work with facilities to install all the required utilities to install the machine on-site
Support writing protocols/reports and executing IQ/PVS/OQ/PQ validation activities 3rd party manufacturing systems
- Monitor the equipment for at least 3 months upon release to production to address any issues
Support Engineers with the installation and validation (IQ/PVS/OQ/PQ) of several off-the-shelf packaging pieces of equipment
Support with new packaging material experimentation
Support early ship testing checks
Support early product and packaging checks
Tray/lid design for Form-Fill-Seal machine, Alloyd, and offload – including tolerances and process alignment (Tyvek repeat checks and such for the FFS)
- Design fixtures and create drawings in CAD software (i.eSolidWorks) to support Production with their day-to-day operations
- Support Engineers in writing SOPs
Qualifications:
. Medical Device Validation (IQ/OQ/PQ)
Sterile Packaging
Form-Fill-Seal Machine Experience
Statistical Analysis: DOEs, ANOVA, Gage R&R, T-Test, Tolerance Analysis Interval, Control Charts and Process Capability
Statistical Software (MiniTab)
CAD Design (i.e SolidWorks)
B.S. in Engineering or Biomedical Engineering
M.S. in Engineering or Biomedical Engineering with 1+ year of professional experience in a Medical Device Manufacturing Environment
