Senior Validation Engineer

Job: Senior Validation Engineer

Location: Milwaukee, WI.

We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.

Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.

Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior/Project Lead Validation Engineer to join our growing team. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.

Summary:

The Senior Validation Engineer is responsible for providing technical leadership and engineering expertise in the commissioning, qualification, and validation of facilities, utilities, equipment, systems, cleaning processes, and manufacturing processes within regulated life sciences environments.

• 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 Subject Matter Expert (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.

• Bachelor’s degree in a related life sciences or requisite industry training and experience
• 5 – 10 years GMP experience
• Ability to converse about scientific matters
• Ability to work independently or in collaboration with others
• In depth understanding and application of validation principles, concepts, practices and standards
• Considered a Subject Matter Expert (SME) in one area of validation
• Proficient in current Good Manufacturing Practices and other applicable regulations
• Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
• Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
• Excellent written communication skills with emphasis in technical writing
• Proficient in Microsoft Word, Excel, Power Point and Project

• Ability to work on a computer for extended periods.
• Ability to sit, stand, and walk project sites for prolonged periods.
• Must be able to travel to job sites occasionally (minimum once per month).

At Compli, you’ll work alongside talented professionals who share your passion for building great things. We offer a people-first culture and a comprehensive benefits package designed to support you personally and professionally, including:

• Medical, dental, and vision insurance
• Life, accident, and disability coverage
• 401(k) with company match
• Employee Assistance Program (EAP) and wellness initiatives
• Paid company holidays, floating holidays, and flexible time off
• Professional development and career advancement opportunities

If you’re ready to work on complex projects and build a career with impact, we’d love to hear from you.

Apply today and grow your future with Compli.

At GBA, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.