Senior Validation Engineer — Lead Life Sciences Projects

GBA; Milwaukee (WI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Employee Assistance Program (EAP) and

wellness initiatives

Job summary

GBA seeks a Senior Validation Engineer to lead commissioning, qualification, and validation across facilities, utilities, equipment, and manufacturing processes in regulated life sciences environments.

You will develop and execute validation plans, protocols, and reports, mentor teammates, and coordinate with manufacturing, quality, and project teams to meet deadlines and regulatory expectations. Strong GMP experience and writing skills are essential.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 5–10 years GMP experience.
• Demonstrated understanding of validation principles and regulatory expectations.
• Excellent written communication and technical writing skills.
• Proficient with GMP, ISPE guidelines and lifecycle deliverables (URS, IQ/OQ/PQ, etc.).
• Strong MS Office and project management tools proficiency.

Responsibilities

• Lead and manage commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, and processes.
• Develop and execute validation lifecycle documentation (plans, protocols, reports, DDS, RTM, etc.).
• Coach and mentor validation specialists and engineers across projects.
• Coordinate protocol execution with multiple stakeholders to meet milestones and regulatory expectations.
• Investigate discrepancies and drive technical issue resolution with sound engineering judgment.

Skills

Scientific communication

Independent work

Validation principles

GMP knowledge

Regulatory compliance

Project management

Mentoring

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

MS Project

Job description

GBA seeks a Senior Validation Engineer to lead commissioning, qualification, and validation across facilities, utilities, equipment, and manufacturing processes in regulated life sciences environments.

You will develop and execute validation plans, protocols, and reports, mentor teammates, and coordinate with manufacturing, quality, and project teams to meet deadlines and regulatory expectations. Strong GMP experience and writing skills are essential.