DPS Engineering Cary , NC 27518
Posted 2 months ago
DPS Group Global is seeking a Project Engineer to support the onboarding and qualification of GMP processing equipment for local gene therapy client. The selected candidate will be working on next-generation gene therapy treatments for highly prevalent and severe chronic diseases. The ideal candidate will have experience with commissioning and qualification lifecycle documentation and activities in addition to strong technical writing skills.
Generate User Requirements Specifications.
Generate and execute IQ and OQ protocols.
Perform gap assessments for vendor IOQ protocols.
Generate and execute gap protocols.
Generate Requirements Traceability Matrices.
Generate Standard Operating Procedures for equipment operation and use.
Equipment includes: Single Thermofisher dynadrive, Sartorius single use mixers, Vanorex micro cell filler, Custom TFF Skid, Depth filtration (Millipore PODS), Cell expansion upstream (simple IOQ).
Purchased Vendor IOQ - gap assessments comparing user requirements vs what vendors have done.
Use and maintenance documents - extracting info from operating manuals.
Calibration and maintenance systems/ Blue mountain maintenance systems.
Skills & Qualifications:
Bachelor's degree preferably in Science, Engineering, or other related field.
2-5 years of relevant related experience.
Experienced with validation to support manufacturing team.
Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders.
Experience working with gene therapy manufacturing equipment preferred.
DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.