Process Engineer – MSAT / Biologics

Novozen Healthcare LLC; Madison (WI); On-site; USD 55,000 - 61,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

Paid time off as required by law

Job summary

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.

Responsibilities

• 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.

Skills

MSAT experience

GMP biologics

Technology transfer

Process scale-up

Master batch records

QTPP / QMS

Documentation writing

Communication

Independent working

Job description

Job Title: Process Engineer - MSAT / Biologics

Location: Madison, WI - Fully Onsite

Employment Type: Contract (W2)

Duration: 12 Months

Job Responsibilities

• Provide MSAT technical expertise supporting GMP biologics drug substance manufacturing.
• Lead technology transfer from process development into manufacturing, translating client development information into executable processes.
• Create and maintain master batch records and process documentation.
• Support process scale-up, manufacturing readiness, and resolution of technical gaps.
• Provide upstream and downstream process support and troubleshoot manufacturing issues.
• Prepare deviation records, technical impact assessments, and associated quality system documentation.
• Collaborate with Manufacturing, Process Development, Quality, and external clients to ensure successful process implementation.
• Apply Quality Target Product Profile (QTPP) principles to manufacturing process design and improvement.

Required Qualifications

• Approximately 3-4 years of relevant process engineering, MSAT, or process development experience.
• Hands-on experience in GMP biologics drug substance manufacturing.
• Strong technology transfer and process scale-up experience.
• Working knowledge of upstream and downstream manufacturing processes, sufficient to contribute with minimal technical training.
• Experience authoring master batch records and technical manufacturing documentation.
• Knowledge of QTPP, manufacturing process design, deviations, impact assessments, and Quality Management Systems (QMS).
• Excellent communication, interpersonal, and client-facing skills.
• Ability to work independently and collaborate across teams in an onsite CDMO environment.

Role Focus: Process engineering, MSAT, and technology transfer. This is not a validation role.

Pay Scale

Anticipated hourly pay range: $40/hr to $44/hr on W2.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.