Process Engineer

Intellectt Inc; New York (NY); On-site; USD 48,000 - 62,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

PTO as required by law

Job summary

Intellectt Inc. is seeking a highly skilled Process Engineer / MSAT Engineer for a 12-month contract in New York. The role focuses on GMP biomanufacturing and technology transfer, acting as the MSAT expert across upstream and downstream operations.

You will lead technology transfer from development to GMP production, oversee scale-up methodologies, and manage QMS documentation including deviation investigations and CAPAs. Strong collaboration with CDMO clients and site teams is required.

Qualifications

• 1–5+ years hands-on process engineering or MSAT in GMP biopharma or CDMO manufacturing.
• Experience with biologics drug substance manufacturing (cell culture/upstream/downstream).
• Knowledge of QTPP, process validation, and Quality by Design (QbD).
• Strong experience with Quality Management Systems (QMS), writing deviation investigations, CAPAs, and risk assessments.

Responsibilities

• Serve as the MSAT technical expert for commercial and clinical GMP biologics drug substance manufacturing.
• Lead technology transfer activities from development to full-scale GMP production.
• Oversee scale-up methodologies, process fit-to-plant assessments, and equipment capability evaluations.
• Author and manage quality documentation within the QMS, including deviation records and change controls.
• Apply QTPP frameworks to evaluate, troubleshoot, and optimize biomanufacturing processes.
• Serve as the primary technical contact during interactions with external CDMO clients and site teams.

Skills

Process engineering

MSAT

GMP biopharma

QbD

QTPP

CAPA

Deviation investigations

Job description

Employment Type & Duration:

Contract (12 Months)

Description:

We are seeking a highly skilled Process Engineer / MSAT Engineer with deep hands‑on bioprocess engineering experience to support GMP biomanufacturing and technology transfer operations.

Responsibilities:

• Serve as the Manufacturing Science and Technology (MSAT) technical expert for commercial and clinical GMP biologics drug substance manufacturing.
• Lead technology transfer activities from process development and client‑provided development packages into full‑scale GMP production.
• Oversee scale‑up methodologies, process fit‑to‑plant assessments, and equipment capability evaluations across upstream and downstream operations.
• Author and manage quality documentation within the QMS, including deviation records, root cause investigations, impact statements, and process change controls.
• Apply Quality Target Product Profile (QTPP) frameworks to evaluate, troubleshoot, and optimize biomanufacturing processes.
• Serve as the primary technical point of contact during routine, daily interactions with external CDMO clients and cross‑functional site teams.

Required Experience & Qualifications:

• 1–5+ years of hands‑on process engineering or MSAT experience within a GMP biopharmaceutical or CDMO manufacturing environment.
• Direct expertise in biologics drug substance manufacturing (cell culture/upstream fermentation and purification/downstream operations).
• Practical knowledge of Quality Target Product Profile (QTPP), process validation principles, and Quality by Design (QbD).
• Strong working experience with Quality Management Systems (QMS), including writing deviation investigations, CAPAs, and risk assessments.

Pay Scale: $35–$45/HR on W2

(Negotiable based on experience)

Benefits:

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.