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
EngineeringValidation SpecialistGill's Process Control Inc. - Rocky
Mount, NC At GPCi we value our team first.Validation Specialist
Assigned Project Manager 8/4/2021Full TimeSalary exempt Our
teammates are the key ingredient that makes usunique. They embody
core values that strengthen our culture and guide our
overallsuccess. Our specialists must be knowledgeable and willing
to go the extra mile in theservice of the client, your success is
our success. We are looking for career minded, team players who
want to grow along with us andcreate an excellent client and
teammate experience! At GPCi, we see every day as a chance to
create a positive impact. We lead throughour values centered on
service, integrity, community and family. From our support ofLocal
Charities, to our Ministry Action Team, our values keep us
dedicated to using ourresources for good: good for our team,
clients, industry and human kind.SUMMARY OF POSITIONThe 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, industryand 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 theirimpact---
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 theability to
walk and carry binders of documents at times (client dependent)---
Plan, schedule, execute protocols and test scripts and communicate
projectstatus.--- Develop a working knowledge of the project
budget, and works to stay withinallotted 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 regulationsSECONDARY
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 statusREQUIREMENTS--- 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 ateam--- 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 remotepositionBUSINESS
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
happensESSENTIAL 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
requirementMEASURES 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
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