Senior Validation Engineer

Job: Senior Validation Engineer

Location: Boulder CO

Lead Projects. Inspire Teams. Build What Matters.

We serve pharmaceutical companies across the United States offering a vast array of services that assist companies with exceeding their goals and todays world its never been more important to understand regulations and quality assurance activities as they relate to operations vendors engineering construction and 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.

• Bachelors 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).

• $145000-$150000 annual salary.

At Compli youll 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

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.