What are the responsibilities and job description for the Senior CQV Engineer position at GBA Team?
Job: 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, its 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 (URSs, 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.
Its more than just a job
At Compli, we are about innovative and intelligent people who want to solve problems. Were 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.
Salary : $80,000 - $120,000