Validation Specialist
Company: GPCi
Location: Rocky Mount
Posted on: January 21, 2023
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Job Description:
The ideal candidate will have a background in Validation
Engineering
Validation Specialist
Gill's Process Control Inc. - Rocky Mount, NC At GPCi we value our
team first.
Validation Specialist Assigned Project Manager 8/4/2021
Full Time
Salary exempt
Our teammates are the key ingredient that makes us
unique. They embody core values that strengthen our culture and
guide our overall
success. Our specialists must be knowledgeable and willing to go
the extra mile in the
service of the client, your success is our success.
We are looking for career minded, team players who want to grow
along with us and
create an excellent client and teammate experience!
At GPCi, we see every day as a chance to create a positive impact.
We lead through
our values centered on service, integrity, community and family.
From our support of
Local Charities, to our Ministry Action Team, our values keep us
dedicated to using our
resources for good: good for our team, clients, industry and human
kind.
SUMMARY OF POSITION
The validation specialist position involves technical writing,
project planning, customer interaction and project management. The
position requires a working knowledge of FDA pharmaceutical
manufacturing regulations and current Good Manufacturing Procedures
(cGMP) as well as excellent technical writing skills, proficiency
in word processing and spreadsheet programs.
A validation specialist is assigned a project and is expected to
work with the client to establish a validation approach, generate
the required life cycle documents to meet cGMP requirements, to be
in compliance with FDA guidelines and client operating procedures.
The documents often include installation and operational
qualification protocols. These protocols may require the validation
specialist to generate test plans and scripts and then assist with
test execution and data collection. The validation specialist will
then generate validation summary reports for the protocols and
change control documents. This position often requires the
development of requirement and design specifications for various
pieces of pharmaceutical manufacturing equipment. Knowledge of
industrial controllers and operator interfaces is required to
generate these specifications.
DUTIES & RESPONSIBILITIES
--- Writing validation plans, test plans, protocols (IQ/OQ/PQ),
test scripts, and reports
--- Execute validation strategies and acceptance criteria based on
established site, industry
and regulatory standards
--- Development or revision of requirement and design
specifications
--- Establishing traceability from specifications to test
scripts
--- Processing change control requests documents
--- In-depth understanding of all system lifecycle deliverables
from Commissioning &
Qualification (C&Q) and Computer System Validation (CSV)
documents
--- Experience with Automated Systems (PLC, HMI)
--- Experience with pharmaceutical manufacturing systems and
equipment such as:
Sterilizers, Isolator technology, Fillers, HVAC systems, and
Utility systems
--- Investigating unexpected events and classifying incidents and
documenting their
impact
--- Performing risk assessments for requested changes to validated
systems
--- Summarize validation results in well organized, accurate and
complete manor
--- Gather information needed to design the protocols by
interacting with clients
--- Route validation documents for initial and final approval, this
will require the
ability to walk and carry binders of documents at times (client
dependent)
--- Plan, schedule, execute protocols and test scripts and
communicate project
status.
--- Develop a working knowledge of the project budget, and works to
stay within
allotted budget for all project aspects
--- Provides weekly update to the client or manager of project
statuses.
--- Schedule and lead project meetings using excellent
communication skills
--- Review client Standard Operating Procedures (SOP), cGMP and FDA
regulations
SECONDARY RESPONSIBILITIES (including but not limited to):
--- Communicate with clients to develop relationships
--- Network with clients and industry associates to develop job
opportunities
--- Complete timesheets, to be submitted daily
--- Meet with manager to communicate project status
REQUIREMENTS
--- 4 - year college degree preferred
--- Proficient In Microsoft Word and Excel
--- 3 or more years or more experience in pharmaceutical
manufacturing environment
--- In-depth understanding of all system lifecycle deliverables
from Commissioning & Qualification (C&Q) and Computer System
Validation (CSV) documents
--- Experience with Automated Systems (PLC, HMI)
--- Experience with pharmaceutical manufacturing systems and
equipment such as: Sterilizers, Isolator technology, Fillers, HVAC
systems, and Utility systems
--- Must be proficient in the ability to write validation protocols
and reports
--- Skilled in technical writing and document control
--- Must have a project management mentality and excellent
communication skills
--- Must have strong organizational skills to maintain data and
documentation
--- Ability to work independently without direction but also able
to work within a
team
--- Proficient with MS Word and Excel
--- Must have valid driver's license and reliable
transportation
--- Must be willing to commute within central to eastern NC - this
is not a remote
position
BUSINESS COMPETENCIES
--- Solid decision making skills
--- Solid problem solving skills
--- Self-management
--- Time management
--- Clear communication to all levels of the team and the
client
--- Capable of managing, communicating and leading change as it
happens
ESSENTIAL FUNCTIONS OF THE JOB
--- Must be able to work in and maintain composure in a fast-paced,
loud environment for long periods of time
--- Must be able to speak, read, write and understand the primary
language(s) used in the workplace
--- Must possess basic math skills (add, subtract, multiply,
divide, calculate percentages)
--- Must be able to work on a computer for long periods of time
--- Must be able to work in a standing position for long periods of
time (up to 9 hours)
--- Must be able to bend, stoop, squat and lift on a regular and
continuing basis
--- Must wear company provided safety equipment (ex. Safety vest,
hard hat,
goggles, safety shoes) when required
--- Meticulously and strictly adhere to all safety policies -
lifting, ladder use, carrying,
ergonomics
--- Must maintain a neat, clean and well-groomed appearance per
GPCi standards
--- Must be able to work on holidays and/or weekends
--- Must be able to meet attendance requirement
MEASURES OF SUCCESS
--- Adherence to GPCi core values
--- Client satisfaction
--- Meeting project/goal deadlines
--- Meeting or beating project budget that is your
responsibility
Keywords: GPCi, Rocky Mount , Validation Specialist, Other , Rocky Mount, North Carolina
Click
here to apply!
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