Senior Validation Engineer
Posted on: January 16, 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)
Validation Engineer Responsibilities:
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 national/international standards.
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
to: Life cycle document management
System requirements and description (URS)
System boundary definition
Design Qualification (DQ) including Functional Design and Software
Design Specification Development
Start Up and Debug documentation
Commissioning document development and execution, including FAT and
Designing and executing engineering studies for critical process
parameter definition and verification prior to validation.
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
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
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 based
Direct experience authoring/editing/executing validation documents
for equipment/facilities/utilities including FAT, IQ, OQ, PQ and
Intermediate knowledge of FDA regulations, ISPE guidelines and ISO
standards including: Good Documentation Practice (GDP) in
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
Perform variety of CQV projects/studies in areas including
Equipment commissioning and qualification, as well as utilities,
facilities, and support systems projects/studies to support
manufacturing. Perform IQ, OQ, PQ of Bioreactors, Refrigerators,
coolers, freezers, flow hoods, BSC, incubators, stability chambers,
cold rooms, water systems, mixers.
If you are qualified, have leadership potential and a willingness
to learn, Verista could be the right career choice for you!
High growth potential and fast paced organization with a
Competitive pay plus performance-based incentive programs
Company paid medical premiums for Employee option.
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 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 or
follow us on .
*Verista is an equal-opportunity employer.
Keywords: Verista, Berkeley , Senior Validation Engineer, Other , Berkeley, California
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