Senior Validation Engineer
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 Include:
- Provide technical CQV (commissioning, qualification, and
verification) expertise on large capital projects involving new or
modified equipment, facilities, and utilities ensuring CQV aspects
are delivered consistently and efficiently. Includes authoring and
executing documents such as URS, System boundary definition, Risk
Assessment, Traceability matrices, Design Qualification, Start Up
and Debug documentation, commissioning documents, including FAT and
SAT, IQ/OQ/PQ, Turnover documentation.
- Author and execute technical commissioning and qualification
documentation for complex, automated equipment, and processes, in
accordance with client's quality standards, current Good
Manufacturing Practices, (21 Code of Federal Regulations Part 210,
211 and 820 level standards which apply to the equipment and
product being validated) and national/international standards.
- Verify system drawings including ability to review and as-build
P&IDs and I&C drawings as well as verifying electrical
schematics with electrical engineering support.
- Manage and work collaboratively with clients' quality
representative to complete deviation investigation and resolution
for problems and issues encountered during execution activities.
Maintain clear and detailed records of qualification and change
control activities for future compliance audits.
- Project assignments will vary by customer requirements for
specific defined deliverables based on project needs and scope.
THIS POSITION IS INTENDED TO SUPPORT CLIENT COMPANIES THROUGHOUT
THE UNITED STATES. CANDIDATES CAN BASE ANYWHERE IN THE US IF THEY
ARE OPEN TO TRAVEL AS NECESSARY.
- A minimum of a bachelor's degree in an Engineering or
- 3+ years' experience in GMP regulated environment
- Technical understanding and experience with automated equipment
for manufacturing, device assembly, and packaging (PLCs, HMIs, PC
- Direct experience authoring/editing/executing validation
documents for equipment/facilities/utilities including FAT, IQ, OQ,
PQ and change controls
- Intermediate to Expert (Senior and Lead) knowledge of FDA
regulations, ISPE guidelines and ISO standards including Good
Documentation Practice (GDP) in pharmaceutical environment
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, Fishers , Senior Validation Engineer, Engineering , Zionsville, Indiana
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