Posted on: March 12, 2023
Verista's 700 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. Our ability to grow is driven by world-class people
who thrive in a team environment and share our mission to enable
life sciences clients to improve lives. Our talented and dedicated
professionals are committed to making an impact every day. Company
Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel
respected, engaged, and challenged
- We constantly acquire new skills and learn from our experiences
to enhance our collective expertise Verista is currently seeking
Validation Engineers with experience in facilities, equipment and
process validation within a pharmaceutical or biotechnology
manufacturing environment to support CQV (Commissioning,
Qualification & Validation) activities. Requirements Validation
- Authoring and executing technical commissioning and
qualification documentation for complex, automated equipment, and
processes, which includes compliance with client's quality
standards, current Good Manufacturing Practices, (21 Code of
Federal Regulations Part 2XX and 8XX level standards which apply to
the equipment and product being validated) and
- Completing commissioning and validation activities taking an
engineering approach including identifying performance issues and
solutions, recommending design or process modification, and
verifying that our clients' equipment maintains SISPQ.
- Authoring, editing, and executing validation documents for
equipment, facilities and/or utilities including but not limited
- Life cycle document management
- System requirements and description (URS)
- System boundary definition
- Traceability matrices
- Design Qualification (DQ) including Functional Design and
Software Design Specification Development
- Start Up and Debug documentation
- Commissioning document development and execution, including FAT
- Turnover documentation
- Designing and executing engineering studies for critical
process parameter definition and verification prior to
- Conducting and documenting impact and risk assessments with a
full understanding of equipment operation and ability to assess
direct, indirect, and no impact systems and functions within
complex, high speed automated process and packaging equipment
- Verifying system drawings including ability to review and
as-built P&IDs (piping and instrumentation drawings) and
I&C (instrumentation and controls) drawings as well as
verifying electrical schematics with support of an electrical
engineer. --- Reading technical schematics to identify, locate, and
test photo sensors, verify part numbers, and complete I/O testing
on automated manufacturing equipment.
- Completing user interface testing, software verification, and
complete alarm testing on automated manufacturing equipment (e.g.,
Rockwell RSView ME user interface and AB ControlLogix PLC).
- Performing onsite validation Verista's clients.
- Developing, reviewing, and completing Installation Check (IC)
documentation; including verification of engineering components,
drawings and specifications utilizing technical engineering
background and expertise.
- Developing and conducting computer system validation.
- Owning entire CQV process for and adherence with project
schedule for all assigned equipment and components.
- Maintaining clear, detailed records of qualification, and
change control activities for future compliance audits.
- Managing and working collaboratively with clients' quality
representative to complete deviation investigation and resolution
for problems and issues encountered during execution activities.
Includes ability to complete root cause analysis and address
complex automated equipment issues to ensure successful validation
- Working with vendors to ensure equipment meets design
intent/specifications (IQ/CQ). You will have:
- This position requires a minimum of a Bachelor's degree in an
Engineering or Scientific degree.
- 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 knowledge of FDA regulations, ISPE guidelines and
ISO standards including:
- Good Documentation Practice (GDP) in pharmaceutical
- ISO 14971 - risk management for medical devices
- ISPE Applied Risk Management for C&Q
- ISPE Science and Risk Based Approach for the delivery of
facilities, systems, and equipment
- ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis
- 21 CFR Part 2XX and 8XX level regulations and interpretation as
applied in the above standards.
- Experience and knowledge of mechanical systems and clean
utilities including ability to read electrical, mechanical,
P&ID (piping and instrument) and facility drawings Desired
- Temperature mapping If you are qualified, have leadership
potential and a willingness to learn, Verista could be the right
career choice for you! Benefits Why Verista?
- High growth potential and fast paced organization with a
- Competitive pay plus performance-based incentive programs
- Company paid medical benefits.
- Company paid Life, Short-Term, and Long-Term Disability
- Dental & Vision insurances
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Leadership development training, career planning, and tuition
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Maternity, Parental Leave and Bereavement Verista is a
leading business, technology and compliance company that enables
clients to improve health and improve lives. We help clients solve
their most critical and complex challenges across the GxP
lifecycle, from preclinical and clinical to commercialization,
manufacturing, and distribution. This experience brings together
decades of knowledge, the most advanced engagement platforms, as
well as transformative technologies. This allows clients to benefit
from the ease, efficiency, and trust that results from working with
one partner who excels across specialties. For more information
about our company, please visit us at Verista.com or follow us on
LinkedIn. For US geography, the salary range for this position is
shown below. The actual salary is dependent upon a variety of
job-related factors such as professional background, training, work
experience, location, business needs, market demand, and
competitive market practice. Therefore, in some circumstances, the
actual salary could fall outside of this expected range. This
salary range is subject to change and may be modified in the
$85,000 - $130,000 *Verista is an equal-opportunity employer.
Keywords: Verista, Logan , Validation Engineer, Engineering , Logan, Utah
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