GMP Validation Engineer: Equipment & Utilities

Stark Pharma Solutions Inc

Frederick (MD)

On-site

USD 90,000 - 130,000

Full time

4 days ago

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Job summary

Stark Pharma Solutions Inc is seeking an experienced Validation Engineer / Validation Specialist to support qualification activities in a GMP manufacturing setting. The role focuses on preparing and executing IQ/OQ/PQ/RQ protocols, generating validation documents, and ensuring compliance with cGMP and GDP standards.

The ideal candidate will bring hands-on validation experience in biotech or pharmaceutical manufacturing, familiarity with aseptic processing, and proficiency with EDMS, RAM, and

Qualifications

Bachelor's degree required with 4+ years validation experience or 8+ years without degree.
Hands-on GMP biotech/pharma validation experience.
Experience with IQ/OQ/PQ/RQ and GDP/cGMP practices.
Experience with aseptic processing and cleanroom environments.

Responsibilities

Prepare and execute IQ/OQ/PQ/RQ protocols and reports for equipment and utilities.
Develop acceptance criteria based on standards and cGMP requirements.
Generate validation summary reports following GDP.
Maintain and revise SOPs related to validation activities.
Support deviations resolution and technical reviews of docs.

Skills

Validation experience

IQ/OQ/PQ/RQ

cGMP knowledge

GDP knowledge

aseptic processing

Documentation skills

Education

Bachelor's degree in Engineering, Science, or a related field

Tools

Kaye AVS

Veriteq dataloggers

EDMS

RAM

LIMS

Microsoft Office

Job description

The ideal candidate will bring hands-on validation experience in biotech or pharmaceutical manufacturing, familiarity with aseptic processing, and proficiency with EDMS, RAM, and

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