Senior CSV Engineer (Labs)
We're currently partnered with a top 10 U.S. Biopharma organization that's currently hiring for a Senior CSV Engineer position who have experience and knowledge with benchtop analytical instruments and lab equipment. If you're looking to grow within a renowned organization and hone in on your CSV skills, then this opportunity is for you.
Key Responsibilities:
- Develop, review, and execute laboratory CSV documentation: Ensure comprehensive creation, meticulous review, and precise execution of Computer System Validation (CSV) documents for laboratory systems.
- Hands-on experience with lab techniques and general lab analytical operations: Apply practical expertise in various laboratory techniques and analytical operations, ensuring accurate and reliable results.
- Complete protocol and qualification activities: Conduct thorough protocol development and qualification activities, ensuring all laboratory processes meet required standards.
- Understanding of baseline lab standards and system suitability verification: Maintain a deep understanding of established laboratory standards and perform system suitability checks to ensure compliance and optimal performance.
- Basic experience with IT system formats, configurations, and workflows: Utilize foundational knowledge of IT system formats, configurations, and workflows to support laboratory operations and data management.
- Document any findings of non-compliance: Accurately record any instances of non-compliance, ensuring transparency and accountability in laboratory practices.
- Assist with strategy regarding remediation activities: Contribute to the development of effective strategies for remediation activities, addressing any identified issues or non-compliance.
- Assist with review of remediation activities: Support the review and evaluation of remediation efforts, ensuring corrective actions are properly implemented and effective.
Key Qualifications:
- Bachelor's degree in Engineering or a related field.
- Extensive experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers, and automated titrators.
- Knowledge of CSA/CSV principles and their application in a lab validation setting.
- Experience in pharmaceutical cGxP environments.
- Proven track record in generating and completing laboratory CSV deliverables.
- Preferred experience with TrackWise, Veeva, DeltaV, and/or Empower.
- Experience in GMP regulated environments.
- Exceptional attention to detail and organizational skills in project work.
- Ability to work independently on assigned tasks without mentorship.
- Strong capability to work both independently and as part of a team.
- Strong problem-solving and critical thinking abilities.
- Excellent organizational and time management skills.
- Meticulous attention to detail.
- Knowledge of GMP and GDP.
- Experience with and adaptability to high levels of challenge and change.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.