Senior GMP Validation Lead

Boehringer Ingelheim GmbH; Spring Valley Estates (GA); On-site; USD 100,000 - 130,000; Full time

Job summary

Boehringer Ingelheim US is seeking a Senior Specialist, Validation to lead GMP validation programs from concept through process validation at the BIAH site, ensuring regulatory compliance and alignment with the Validation Master Plan.

The role oversees SOP development, CAPA assessment, audits, and coordination of cross-functional teams, with a focus on ensuring inspection readiness and continuous improvement.

Qualifications

• Bachelor Degree in a relevant scientific, bioengineering or related discipline.
• Minimum GMP validation experience with leading projects and cross-functional teams.
• Ability to plan, schedule, organize and coordinate validation activities.
• Excellent written and verbal communication skills.

Responsibilities

• Lead high-level GMP validation projects from concept through process validation.
• Maintain validation databases and document systems; support feasibility studies.
• Develop SOPs and training on quality principles.
• Oversee audits, CAPA assessments, change controls and deviations.
• Provide technical support for URS/FDV/DS for systems and equipment.

Skills

GMP validation leadership

Project management

Quality systems

SOP development

CAPA & deviation handling

Audit support

Staff training

Document review

Education

Bachelor Degree in a relevant scientific discipline

Tools

MS Word

MS Excel

MS Outlook

PowerPoint

Job description

Boehringer Ingelheim US is seeking a Senior Specialist, Validation to lead GMP validation programs from concept through process validation at the BIAH site, ensuring regulatory compliance and alignment with the Validation Master Plan.

The role oversees SOP development, CAPA assessment, audits, and coordination of cross-functional teams, with a focus on ensuring inspection readiness and continuous improvement.