Senior Validation Engineer - Lead GMP & CSV Programs

Beacon Hill Staffing Group, LLC; Indianapolis (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Paid time off and leave programs

Flexible work arrangements

Job summary

Beacon Hill Staffing Group, LLC is seeking a Senior Validation Engineer to lead validation, qualification, and calibration activities across manufacturing and laboratory environments. The role ensures equipment, utilities, and computer systems meet regulatory and quality standards.

Ideal candidates will drive validation strategies, author IQ/OQ/PQ protocols, and oversee calibration programs while supporting regulatory inspections and continuous improvement initiatives.

Qualifications

• Bachelor's degree in a technical field is required.
• 5+ years in validation, qualification, calibration, or commissioning in GMP settings.
• Strong understanding of cGMP, FDA requirements, and Data Integrity principles.
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Experience supporting equipment qualification, utilities validation, and manufacturing systems.

Responsibilities

• Lead validation activities from project planning through execution and final approval.
• Develop and maintain Validation Master Plans (VMPs) and validation strategies.
• Author, review, and execute IQ, OQ, and PQ protocols and tests.
• Support capital expansion, facility upgrades, and process improvements.
• Oversee calibration documentation and traceability requirements.
• Ensure compliance with regulatory and quality standards across systems.

Skills

Technical writing

Project management

Regulatory knowledge

Quality systems

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical discipline

Tools

Kneat

ValGenesis

MasterControl

Veeva

TrackWise

Job description

Beacon Hill Staffing Group, LLC is seeking a Senior Validation Engineer to lead validation, qualification, and calibration activities across manufacturing and laboratory environments. The role ensures equipment, utilities, and computer systems meet regulatory and quality standards.

Ideal candidates will drive validation strategies, author IQ/OQ/PQ protocols, and oversee calibration programs while supporting regulatory inspections and continuous improvement initiatives.