Validation Engineer
Company: GlaxoSmithKline
Location: Rockville
Posted on: January 24, 2023
Job Description:
Site Name: USA - Maryland - RockvillePosted Date: Dec 22 2022GSK
is currently looking for a Validation engineer to join our team in
Rockville, MD. The primary responsibility is to support the
qualification of GxP analytical instruments, computerized systems
as well as utilities and process equipment across GMS Rockville for
various capital projects. Assure that the validation program is
compliant with global, site and industry practices.KEY
RESPONSIBILITIES:
- Supports facility, process equipment, analytical instrument,
computerized system qualification/validationactivities for various
capitalprojects by writing and executingvalidation protocols and
all required validation lifecycle documents ensuring compliance
withcGMPsas well as above site policies and procedures.
- Authors final reports summarizing
executionofvalidationprotocols and support documents (amendments,
repeat test forms, addenda and deviations).
- Responsible for continuous improvement of validation programand
assuring compliance with GSK policies and procedures.
- Interface with Validation, Quality Assurance, Engineering,
System Owners and key stakeholders to facilitate timely protocol
execution and remediate issues during protocol execution.
- Interface with regulatory authorities and partners as the SME
for the validation program.
- Provide leadership and technical decision-making regarding cGMP
compliance, validation strategy, and quality systems.
- Schedule and coordinate validation activities
withvendors,system owners,engineeringand key stakeholders.
- Participate in change control reviews.
- Ensure timely CAPA andchange controlexecution and closure.
- Participates in site projects and initiatives as necessary.
- Trainedinself inspections and participate in > 25% of
department's selfinspections.Why you?Basic Qualifications:We are
looking for professionals with these required skills to achieve our
goals:
- BS/BA in a Scientific, Engineering, Computer Science or
equivalent related discipline
- Minimum of 3 years of industry-related experience (Validation,
QA, QC, manufacturing) and 1+ year of hands-on validation
experience.Preferred Qualifications:If you have the following
characteristics, it would be a plus:
- Solid organization, problem-solving, decision-making, judgment,
leadership, and team-oriented skills are essential to manage
multiple projects of variable complexity.
- ExperiencewithSAPandVeevais preferred.
- Familiar with the operation and qualification of utilities,
process equipment, computerized systems and analytical instruments
used within biopharmaceutical manufacturing and QC labs
- High level of IT literacy and experience with IT applicationsis
preferred(SAP, Veeva,DeltaV, PLCs, Unicorn, Siemens Building
Automation System, etc.).
- Understanding of the requirements of a Biopharma/regulated
environment.
- Solid interpersonal skills are required in order to effectively
communicate with all levels of the organization in various
functional areas.
- Extensive knowledge of 21CFR11 requirements.
- Strong planning and program management skills.
- Effective organization, communication, presentation and
influencing skills.Why GSK?GSK is a global biopharma company with a
special purpose -to unite science, technology and talent to get
ahead of disease together -so we can positively impact the health
of billions of people and deliver stronger, more sustainable
shareholder returns -as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and
we aim to impact the health of 2.5 billion people around the world
in the next 10 years. Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for
patients and shareholders, it's also about making GSK a place where
people can thrive. We want GSK to be a place where people feel
inspired, encouraged and challenged to be the best they can be. A
place where they can be themselves -feeling welcome, valued and
included. Where they can keep growing and look after their
wellbeing. So, if you share our ambition, join us at this exciting
moment in our journey to get Ahead
Together.#LI-GSK#GlobalSupplyChainGSK is a global biopharma company
with a special purpose - to unite science, technology and talent to
get ahead of disease together - so we can positively impact the
health of billions of people and deliver stronger, more sustainable
shareholder returns - as an organisation where people can thrive.
Getting ahead means preventing disease as well as treating it, and
we aim to impact the health of 2.5 billion people around the world
in the next 10 years.Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for
patients and shareholders, it's also about making GSK a place where
people can thrive. We want GSK to be a workplace where everyone can
feel a sense of belonging and thrive as set out in our Equal and
Inclusive Treatment of Employees policy. We're committed to being
more proactive at all levels so that our workforce reflects the
communities we work and hire in, and our GSK leadership reflects
our GSK workforce.If you require an accommodation or other
assistance to apply for a job at GSK, please contact the GSK
Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155
(outside US).GSK is an Equal Opportunity Employer and, in the US,
we adhere to Affirmative Action principles. This ensures that all
qualified applicants will receive equal consideration for
employment without regard to race, color, national origin,
religion, sex, pregnancy, marital status, sexual orientation,
gender identity/expression, age, disability, genetic information,
military service, covered/protected veteran status or any other
federal, state or local protected class.At GSK, the health and
safety of our employees are of paramount importance. As a
science-led healthcare company on a mission to get ahead of disease
together, we believe that supporting vaccination against COVID-19
is the single best thing we can do in the US to ensure the health
and safety of our employees, complementary workers, workplaces,
customers, consumers, communities, and the patients we serve.GSK
has made the decision to require all US employees to be fully
vaccinated against COVID-19, where allowed by state or local law
and where vaccine supply is readily available. The only exceptions
to this requirement are employees who are approved for an
accommodation for religious, medical or disability-related
reasons.Important notice to Employment businesses/ AgenciesGSK does
not accept referrals from employment businesses and/or employment
agencies in respect of the vacancies posted on this site. All
employment businesses/agencies are required to contact GSK's
commercial and general procurement/human resources department to
obtain prior written authorization before referring any candidates
to GSK. The obtaining of prior written authorization is a condition
precedent to any agreement (verbal or written) between the
employment business/ agency and GSK. In the absence of such written
authorization being obtained any actions undertaken by the
employment business/agency shall be deemed to have been performed
without the consent or contractual agreement of GSK. GSK shall
therefore not be liable for any fees arising from such actions or
any fees arising from any referrals by employment
businesses/agencies in respect of the vacancies posted on this
site.Please note that if you are a US Licensed Healthcare
Professional or Healthcare Professional as defined by the laws of
the state issuing your license, GSK may be required to capture and
report expenses GSK incurs, on your behalf, in the event you are
afforded an interview for employment. This capture of applicable
transfers of value is necessary to ensure GSK's compliance to all
federal and state US Transparency requirements. For more
information, please visit GSK's Transparency Reporting site.
Keywords: GlaxoSmithKline, Rockville , Validation Engineer, Engineering , Rockville, Maryland
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