Process risk assessment jobs

Process Engineer Sr.

SeAH Superalloy Technologies · Posted Nov 10, 2026

Open

Temple, Texas, United States
On-site
Full-time · Senior

Process Engineer Sr.

SeAH Superalloy Technologies · Posted Nov 10, 2026

Open

Temple, Texas, United States
On-site
Full-time · Senior

Process Engineer

Aditi Consulting · Posted Nov 10, 2026

Open

Princeton, New Jersey, United States
Full-time
$60–$60 per hour
5+ years

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Technical leadership and support for cGMP cell therapy manufacturing at Princeton, NJ

Compensation

Payrate: $60.00 - $60.00/hr

Responsibilities

Process Subject Matter Expert and process owner for technology transfer and new product introduction
Perform technology transfer facility, process, workflow, and equipment fit assessment, process gap analysis, and process risk assessment when on-boarding new programs
Author, review, and approve internal cGMP technical documents (e.g., Batch records, SOPs, Sample Plans, and protocols)
Author and approve protocols and reports per internal and external regulatory expectations
Provide on-the-floor technical support to manufacturing including process execution and troubleshooting, Quality Event triage, root cause analysis, and CAPA implementation

Requirements

BSc and/or Advanced degree in Science or Chem/Bio Engineering
Nice to have: Advanced degree
Nice to have: familiarity with cell therapy processes
Nice to have: cleanroom facilities
Nice to have: equipment qualification

Skills

technology transfer cGMP

Senior Scientist, Upstream, Late-Stage Process Development

AGC Biologics · Posted Nov 10, 2026

Open

Copenhagen, Capital Region, Denmark +1 more
On-site
Full-time · Senior
5+ years

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Lead upstream late-stage development activities, focusing on process characterization, down-scale model qualification, and scientific data analysis for mammalian cell culture processes.

Locations (2)

Copenhagen, Capital Region, Denmark
Søborg, Capital Region, Denmark

Responsibilities

Plan and lead process characterization studies
Design and evaluate down-scale model qualification studies
Apply statistical methods and tools such as JMP
Contribute to FMECA and process risk assessments
Support late-stage development activities including LIVCA, WCB, scale-up, and technology transfer

Requirements

Bachelor's, Master's, or PhD in biotechnology, biochemical engineering, or related discipline
Nice to have: AMBR250
Nice to have: DSMQ
Nice to have: Statistical equivalence testing
Nice to have: Process modelling

Process Engineer Sr.

Process Engineer Sr.

Responsibilities

Requirements

Skills

Process Engineer

Compensation

Responsibilities

Requirements

Skills

Senior Scientist, Upstream, Late-Stage Process Development

Locations (2)

Responsibilities

Requirements

Skills

Benefits

Benefits