Biologics MSAT Engineer - Tech Transfer & Scale-Up (Onsite)

Novozen Healthcare LLC; Madison (WI); Sur place; USD 55 000 - 61 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) retirement plan

Paid time off as required by law

Résumé du poste

Novozen Healthcare LLC in Madison, WI is seeking a Process Engineer - MSAT / Biologics for a 12-month contract (W2), onsite at our CDMO facility. You will support GMP biologics manufacturing, lead tech transfer, and ensure process readiness while developing master batch records and documentation.

Ideal candidates bring 3-4 years in MSAT or process development with strong transfer and scale-up experience, and the ability to collaborate cross-functionally in an onsite environment.

Qualifications

• 3-4 years of process engineering/ MSAT or development experience.
• GMP biologics drug substance manufacturing experience.
• Strong tech transfer and scale-up experience.
• Knowledge of upstream and downstream processes for cross-functional support.
• Experience authoring master batch records and manufacturing docs.
• Familiar with QTPP, process design, deviations, and QMS.
• Excellent communication and client-facing skills.
• Ability to work independently in an onsite CDMO environment.

Responsabilités

• Provide MSAT expertise supporting GMP biologics manufacturing.
• Lead tech transfer from development to manufacturing and translate data into processes.
• Create and maintain master batch records and process documentation.
• Support process scale-up, readiness, and gap resolution.
• Provide upstream/downstream process support and troubleshoot issues.
• Prepare deviation records and quality system docs.
• Collaborate with Manufacturing, Process Development, Quality, and clients.
• Apply QTPP principles to process design and improvement.

Connaissances

MSAT experience

GMP biologics

Technology transfer

Process scale-up

Master batch records

QTPP / QMS

Documentation writing

Communication

Independent working

Description du poste

Novozen Healthcare LLC in Madison, WI is seeking a Process Engineer - MSAT / Biologics for a 12-month contract (W2), onsite at our CDMO facility. You will support GMP biologics manufacturing, lead tech transfer, and ensure process readiness while developing master batch records and documentation.

Ideal candidates bring 3-4 years in MSAT or process development with strong transfer and scale-up experience, and the ability to collaborate cross-functionally in an onsite environment.