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Senior Validation Engineer

GBA

Boulder, COJob$80–120K/yrSeen todaySeen in employer's feed today

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At a glance

Compensation
$80–120K/yr
Location
Boulder, CO
Work Authorization
Not specified

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Job overview

The Senior Validation Engineer provides commissioning, qualification, and validation project deliverables for life sciences clients. The work includes lifecycle validation documentation, CQV protocols, protocol execution, and summary and final report packages. The role prefers prior experience with specified systems and equipment, pharmaceutical or biotech manufacturing, and relevant regulations. The posting requires at least five years of commissioning, qualification, and validation experience.

Skills & qualifications

RequiredNice to have

Skills

CommissioningQualificationValidationHVAC SystemsPurified Water SystemsWater for Injection SystemsLyophilizersFreeze DryersSpray DryersAseptic Fill LinesBlending EquipmentPharmaceutical ManufacturingBiotech ManufacturingCurrent Good Manufacturing PracticesPharmaceutical RegulationsBiotech RegulationsInterpersonal SkillsCommunicationCritical Thinking

Qualifications

Bachelor's in Science or Related5+ Years Commissioning, Qualification, and Validation ExperiencePrior Pharmaceutical or Biotech Manufacturing Experience

Full job description

Sr. Validation Engineer Location : Broomfield, CO and Lenexa, KS Compli, LLC, a George Butler Associates' affiliate, was founded in 2001 to provide commissioning, validation and regulatory support services to the life sciences industry. We serve pharmaceutical and life science companies across North America. With regard to regulations and compliance, it's never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction and contractors, which is why clients trust the Compli team. - **What You'll Do:**Efforts consist of providing commissioning, qualification and validation project deliverables to clients around Lifecycle validation efforts. - This included, but is not limited to, developing Lifecycle documentation (URS's, Trace Matrices, System/Component Impact Assessments, Risk Assessments, Master Planning, etc.), developing Commissioning, Qualification and Validation documentation (CQV protocols, executing protocols, developing summary reports and final report packages). - Collate and analyze data and prepare Summary Reports. - Perform all other tasks, and projects. - Other duties as assigned. - **What You'll Bring:**Preferred prior experience in performing CQV services on the following systems / equipment: - Utilities including HVAC systems and Purified Water / Water for Injection Systems - Lyophilizers / Freeze Dryers - Spray Dryers - Aseptic Fill Lines and associated equipment - Blending Equipment - BS in science related field (e.g., engineering, biology, microbiology, chemistry, etc.). - Minimum 5+ years' experience specific to commissioning, qualification and validation activities. - Prior experience in the pharmaceutical / biotech manufacturing industry. - Prior experience with Current Good Manufacturing Practices and other relevant regulations related to the Pharmaceutical / Biotech industry. - Must have strong interpersonal and communication skills. - Must have strong critical thinking skills. Travel : Local personnel preferred. Compensation : $80,000 to $120,000 annually based on experience level and location. *This role is not open to C2C staffing. It's more than just a job... At Compli, we are about innovative and intelligent people who want to solve problems. We're known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology. At Compli, 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.Please Apply at: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjA4MzU2Ljg3NjBAZ2JhdGVhbWNvbXAuYXBsaXRyYWsuY29t{rel="noopener noreferrer" target="_blank"}

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