Senior Validation Engineer — Lead GMP/QA in Life Sciences

Compli; Milwaukee (WI); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Life, disability coverage

Paid holidays and flexible time off

Professional development opportunities

Job summary

Compli in Milwaukee is seeking a Senior Validation Engineer to lead commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, cleaning, and manufacturing processes in regulated life sciences environments.

You will develop lifecycle documents (URS, IQ/OQ/PQ, FAT/SAT) and provide SME guidance across projects, including greenfield construction and renovations. Strong GMP and writing skills are required; travel to job sites monthly is anticipated.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5–10 years GMP experience.
• Strong written and technical communication skills.
• Ability to work independently or with others.
• SME in at least one area of validation.
• Proficient with GMP regulations and ISPE guidelines.
• Experience with validation lifecycle deliverables (URS, IQ/OQ/PQ, FAT/SAT).

Responsibilities

• Lead and support commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, cleaning, and manufacturing processes.
• Develop and execute commissioning and validation lifecycle documentation, including validation plans, protocols, test scripts, reports, and supporting documentation.
• Develop project-specific commissioning, qualification, and validation strategies based on system requirements, risk, intended use, and regulatory expectations.
• Provide technical leadership throughout all phases of projects, including greenfield construction, facility renovations, equipment installation, new product development, product launch, and process or system upgrades.
• Lead and perform system, equipment, and process risk assessments and technical analyses.
• Review engineering and system documentation to ensure alignment with validation requirements and regulatory expectations.
• Develop, review, and execute applicable system lifecycle deliverables, including URS, SRS, FRS, DDS, RTM, FAT, SAT, IQ, OQ, PQ, and Final Validation Summary Reports.
• Author and review validation and qualification protocols, technical reports, operating procedures, and other controlled documentation.
• Investigate and resolve validation discrepancies, deviations, and technical issues using sound engineering judgment and practical problem-solving approaches.
• Schedule and coordinate protocol execution with manufacturing, facilities, engineering, quality, project management, contractors, and other project stakeholders.
• Manage multiple validation projects and priorities while meeting established project milestones and deadlines.
• Provide technical guidance and mentorship to validation specialists, engineers, and other project team members as appropriate.
• Serve as a technical resource and SME in one or more areas of validation, qualification, or regulatory compliance.
• Interface confidently and professionally with clients, contractors, management, regulatory and quality personnel, and project teams.
• Support continuous improvement of validation practices, standards, templates, and execution strategies.
• Other duties as assigned.

Skills

GMP experience

Technical writing

MS Word

MS Excel

PowerPoint

Project management

Education

Bachelor's degree in Life Sciences or related field

Tools

TrackWise

Job description

Compli in Milwaukee is seeking a Senior Validation Engineer to lead commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, cleaning, and manufacturing processes in regulated life sciences environments.

You will develop lifecycle documents (URS, IQ/OQ/PQ, FAT/SAT) and provide SME guidance across projects, including greenfield construction and renovations. Strong GMP and writing skills are required; travel to job sites monthly is anticipated.