Onsite Senior Validation Engineer — GMP & Process

Piper Companies; Georgia; On-site; USD 96,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

401(k)

Job summary

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client. This role centers on validation activities within a regulated GMP environment, covering fill/finish operations, equipment qualification, process validation, and compliance initiatives.

The Senior Validation Engineer will lead validation strategy, execution, investigations, and change management across critical manufacturing systems.

Qualifications

• 7+ years of validation, quality, or related experience in pharmaceutical or medical device industries.
• Strong knowledge of GMP manufacturing environments and validation lifecycle activities.
• Experience with regulatory standards including 21 CFR Part 11, GAMP5, ISO, FDA, and ICH guidance.

Responsibilities

• Prepare, execute, analyze data, and report IQ/OQ/PQ protocols.
• Own Change Requests related to validation activities.
• Author and review Validation Plans, PQMPs, protocols, reports, and validation documentation.
• Execute validation activities for direct-impact systems, equipment, and processes.
• Perform compliance reviews and technical approvals of validation data.

Skills

Validation expertise

GMP environment

Project leadership

Root cause analysis

Documentation

Cross-functional collaboration

Education

Bachelor's degree

Master's degree preferred

Tools

Validation protocols

Job description

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client. This role centers on validation activities within a regulated GMP environment, covering fill/finish operations, equipment qualification, process validation, and compliance initiatives.

The Senior Validation Engineer will lead validation strategy, execution, investigations, and change management across critical manufacturing systems.