Senior Process Engineer

Job Title : Senior Process Engineer

Location: Summit, NJ

Duration: 12+ Months

Job Description :

Were looking for a Senior Process Engineer to lead critical initiatives around Process Performance

Qualification (PPQ) and operational readiness assessments across multiple sites. This is your opportunity to play a pivotal role in shaping the future of monoclonal antibody manufacturing

What You'll Do:

Lead pFMEA assessments and evaluate tech transfer readiness

identify gaps and drive root cause analysis and CAPA implementation

Support cross-functional validation efforts across manufacturing, QC. 0A, and more

Bring deep technical insight into biopharma operations, from cell therapy to fill/finish

Report and communicate key findings directly to senior leadership

What You Bring

Bachelor's in Engineering or related field

6-10 years of industry experience

Expertise in pFMEAs, PPQs, and validation strategy.

knowledge of IS0 spaces and regulatory audit expectations

Strong communication and project management skills