Senior Validation Engineer — Onsite GMP Leader (Pharma)

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

Benefits offered by this job

Medical, dental, vision

401(k)

Long-term contract opportunity

Job summary

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

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

Qualifications

• 7+ years of validation, quality, or related experience in pharmaceutical or medical device industries.
• Strong GMP knowledge and validation lifecycle experience.
• Proven experience with regulatory standards such as 21 CFR Part 11, GAMP5, ISO, FDA, and ICH guidance.
• Demonstrated investigations and root cause analysis skills.
• Ability to author and review technical documents, protocols, and procedures.
• Proven project leadership and cross-functional collaboration abilities.
• Pharma fill/finish experience preferred.

Responsibilities

• Provide validation support through IQ/OQ/PQ protocol preparation, execution, data analysis, and reporting.
• Own change requests related to validation activities and deliverables.
• Author and review validation plans, master plans, protocols, and validation reports.
• Execute validation activities for systems, equipment, and processes to meet timelines.
• Lead validations investigations, deviations, and non-conformances with root-cause analysis.
• Ensure compliance with local, corporate, and regulatory requirements.
• Develop/Revise validation procedures, CILs, specifications, and SOPs as needed.
• Support FAT, SAT, commissioning, qualification, and startup activities for equipment and processes.
• Identify process improvements and support continuous improvement initiatives.
• Provide contractor oversight, project coordination, and budget support.
• Lead validation activities and serve as SME for new system implementations.

Education

Bachelor’s degree in Engineering or related technical field

Master’s degree preferred

Job description

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

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