Quality Engineer (Manufacturing Validation)
? Chicago, IL (Hybrid)
? $45–$60/hr
? 6-Month Contract (Potential for Extension)
Company Overview
Nemera is a global contract manufacturer specializing in drug delivery devices for the pharmaceutical and biotechnology industries. Their Chicago team is launching a new assembly program focused on subassembly systems for drug delivery products and is seeking a hands-on Quality Engineer to support this critical initiative.
Position Overview
This role is heavily focused on Manufacturing Quality and process validation. The team has incoming inspection established but needs support building and implementing batch release processes, in-process quality controls, and overall operational quality flow. This is a ground-up validation effort — no validation structure is currently in place — making this an excellent opportunity for someone who enjoys building systems from scratch.
The environment is currently manual and semi-automated, operating much like an engineering prototype at scale before full automation is introduced. This role requires a creative, problem-solving mindset and strong understanding of how manufacturing processes tie into product risk and overall device performance.
Key Responsibilities
Develop and execute IQ/OQ/PQ process validations for manufacturing operations
Establish in-process quality controls and batch release processes
Support the launch of a new assembly program for drug delivery subassemblies
Define where quality checkpoints belong within a manual/semi-automated manufacturing flow
Assess process risks and understand product impact (e.g., missing components, assembly defects, etc.)
Collaborate cross-functionally with Manufacturing and Product Development teams
Support documentation and administrative work (remote flexibility available for this portion)
Ideal Background
Strong experience validating manufacturing processes (IQ/OQ/PQ required)
Experience in medical device manufacturing preferred
Background in Product Development is highly desirable
Experience working in semi-automated environments
Ability to understand process control and product risk relationships
Comfortable working in early-phase or “prove-out” production environments
Hands-on, creative problem solver who can build validation systems from the ground up
Work Arrangement
Contract Details
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.