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. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.

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.

As CGV Engineer, you'll have the unique opportunity to work within an integrated Architecture, Engineering, and Construction firm capable of executing ONEsolution integrated project delivery work. Experience collaboration and continuous learning like never before amongst subject matter experts spanning across mechanical, electrical, plumbing, process, and automation engineering; architecture and lab planning; procurement, estimation, virtual design & construction, health & safety, and construction management. This diversity of professionals allows us to provide innovative & impactful solutions to the Life Sciences in an era where speed, quality, and creativity have never been more critical.  

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. CQV projects can be part of small or large capital projects or standalone compliance efforts.
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 cross-discipline project team coordination
• Read, understand and utilize cGMP compliance-based 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 
  and issues, to ensure RFT delivery
• 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 compliance-based 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

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

Additional Qualifications

• 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

CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.