Lead Validation Engineer - GMP & Fill/Finish Ops

Piper Companies; Iowa (LA); On-site; USD 96,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)

Long-term contract

On-site role with project stability

Job summary

Piper Companies is seeking a Senior Validation Engineer to lead validation strategy and execution in a GMP environment for fill/finish operations and equipment qualification. This role emphasizes technical leadership, investigations, and change management across critical manufacturing systems.

The position requires 7+ years in pharma validation, strong regulatory knowledge, and the ability to author extensive documentation.

Qualifications

• 7+ years of validation, quality, or related experience in pharma/medical devices.
• Strong knowledge of GMP manufacturing environments and validation lifecycle activities.
• Experience with regulatory standards including 21 CFR Part 11, GAMP5, ISO, FDA, ICH.
• Ability to author and review technical documentation, protocols, reports, and procedures.
• Demonstrated project leadership and cross-functional collaboration.

Responsibilities

• Provide validation and technical support through IQ/OQ/PQ protocols and data analysis.
• Own Change Requests related to validation activities and deliverables.
• Author and review Validation Plans, PQMPs, protocols, and validation reports.
• Execute validation activities for direct-impact systems and processes on schedule.
• Lead investigations, deviations, and non-conformances using root cause analysis.
• Ensure activities comply with regulatory requirements and internal standards.
• Support FAT, SAT, commissioning, qualification, and startup of equipment and processes.
• Identify process improvements and support continuous improvement initiatives.

Skills

Validation leadership

GMP experience

Root cause analysis

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Engineering/CS

Master’s degree preferred

Tools

Quality systems software

Job description

Piper Companies is seeking a Senior Validation Engineer to lead validation strategy and execution in a GMP environment for fill/finish operations and equipment qualification. This role emphasizes technical leadership, investigations, and change management across critical manufacturing systems.

The position requires 7+ years in pharma validation, strong regulatory knowledge, and the ability to author extensive documentation.