Cqv Engineer,100%
vor 1 Woche
CRB's nearly 1,800 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries.
As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet.
From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.
In Europe, CRB has developed its presence through its DACH located offices respectively in Basle, Switzerland and Böblingen, Germany.Job Description:
How will you contribute?
Your work will ensure that our Clients have a Right-the-First Time (RFT) solution that has mitigated risks and met their compliance and timeline objectives.
Commissioning, Qualification & Validation (CQV) focuses on early-stage planning, preparation, management of compliant execution (EU) and documentation of CQV work within the GMP regulated Pharmaceutical/Life Sciences space.
- conducting commissioning tests and execution of CQV protocols following established 21 CFR standards and templates, including but not limited to the following: Commissioning Forms, Validation Protocols, Standard Operating Procedures, Protocols or Reports for FATs, SATs, IQ/OQ/PQs- Project work may include all levels of CQV such as protocol generation, execution and reporting once more experience was gained in the role
- Ability to develop CQV related documents ( Spec's, Risk assessments, protocols, Forms, Reports)
- Proficient with basic internal and external crossdiscipline project team coordination
- Read, understand and utilize cGMP compliancebased services with Trade Partners and Clients as defined by the Project Scope
- Perform work to meet CRB budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to CRB project leaders, project managers, or management, of project status
- Provide investigational & troubleshooting support encountered during execution activities
- Provides technical training to Client staffing to enhance speed of startup activities Read, understand and utilize cGMP compliancebased services with Trade Partners and Clients as defined by the Project Scope
- Provide consistent, complete, and timely feedback and reports to CRB project leaders, project managers, or management, of project status and issues, to ensure RFT delivery
- Peer review of CQV documents following established 21 CFR standards and templates
Qualifications:
Minimum Qualifications
- Ideally over 5 years of experience of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries such as animal health or Food & Beverage.
- Fundamental education, apprenticeship or bachelor's degree in pharma, animal health or food &beverage related field preferred or related level of experience
- Excellent organizational, interpersonal, presentation, collaboration, communication and interpersonal skills
- Experience in Pharmaceutical, Biotech, Food & Beverage, Medical Device Design, Construction, Commissioning, Validation, or QA
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software is a plus
- Experience with Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the U.S. FDA would be a strong asset
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