Senior CQV Validation Engineer - GMP Biotech

ACL Digital

New Albany (OH)

On-site

USD 110,000 - 150,000

Full time

14 days+

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Job summary

ACL Digital is seeking a Senior Validation Process Development Engineer to lead CQV activities in a GMP-regulated biotechnology environment. You will drive development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes to support commercial production.

You will provide day-to-day technical manufacturing support, perform deviation investigations, root cause analysis, and implement continuous improvement to enhance

Qualifications

Doctorate or Masters with experience; alternative pathways per basic quals.
Experience in CQV within GMP biotech/pharma environments.
Experience supporting packaging and device assembly processes.

Responsibilities

Characterization test protocols and reports.
CQV test protocols and reports for equipment, systems, and processes.
Engineering studies and technical assessments.
Validation Master Plans, Plans and Summary Reports.
Reports supporting lifecycle management, technology transfers, and NPI.
Lead complex engineering initiatives; SME for combination products and GMP processes.

Skills

CQV leadership

GMP manufacturing

Packaging equipment

Combination products

Device assembly

QMS software

Deviation investigations

Root cause analysis

Continuous improvement

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma / GED

Tools

KNEAT

Veeva

TrackWise

Change controls

CAPA management

Job description

You will provide day-to-day technical manufacturing support, perform deviation investigations, root cause analysis, and implement continuous improvement to enhance

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