Senior Validation Engineer
Location: Baton Rouge
Posted on: August 7, 2022
Looking for an exciting opportunity at a fast growing,
employee-oriented company? Verista's 500+ experts team up with the
world's most recognizable brands in the life science industry to
solve their business needs. Whether it's compliance, quality
management, verification, validation, automation, IT
infrastructure, data analysis, manufacturing, or packaging, we
deliver solutions that are right the first time.
Verista's experts include SMEs across the spectrum of pharma,
medical devices and biotech industries. As a result, we're uniquely
capable of offering transformative, integrated solutions, new
perspectives, and consistent results.
Our ability to grow is driven by world-class people who thrive in a
team environment and share our mission to enable our clients to
improve the quality of patient healthcare worldwide. Our talented
and dedicated professionals are committed to making an impact every
We deliver solutions that are right the first time.
Typical Responsibilities of a Senior Validation Engineer:
- Assesses client computer systems and identify any potential
Part 11 or Annex 11 gaps to ensure data integrity best practices
- Review off-the-shelf software, software development tools and
software systems used in quality processes to determine appropriate
- Provide routine progress and issue update to project team.
- Execute Commissioning, Installation, Operation and Performance
Qualification Protocols for various life science lab, computer
system, analytical instruments and manufacturing equipment and
- Generate/Revise/Execute system life cycle deliverables (e.g.,
URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance
testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final
Validation Summary Report).
- Ensuring that project deliverables are compliant with all
applicable regulations including FDA's GLP, GCP and GMP/Part 11 and
EU Annex 11 and industry guidelines like ISPE GAMP5.
- Prepare and execute SAP qualification.
- You've earned your BS in chemical, biomedical, or biochemical
engineering, biological sciences, or related field/experience.
- You've gained 2-10 years relevant industry experience working
in a cGMP environment.
- You've got working knowledge of cGMP manufacturing as well as
regulatory regulations and requirements for biotechnology,
pharmaceuticals, and medical devices in your toolbox.
- You've collected previous experience in writing and executing
Validation protocols such as Installation, Operation and
Performance Qualification documents.
- Experience with SAP, LIMS and Trackwise.
Because employees are the key to our success, Verista offers strong
benefits and incentives including:
- Health, Dental, and Vision Insurance
- 401(k) Retirement Plan with a company match
- Paid Time Off Pay
- Tuition Reimbursement
- 9 Company Paid Holidays
- Paid Long Term & Short Term Disability Insurance
- Training and Development
- Paid Maternity Leave and Parental Leave
- Travel Bonus
- Employee Referral Program
- Tuition Reimbursement
- Marriage Leave
- Verista is an Equal Opportunity Employer
Keywords: Verista, Baton Rouge , Senior Validation Engineer, Engineering , Baton Rouge, Louisiana
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