Validation Engineer III, Equipment & CSV
Company: Disability Solutions
Location: Greenville
Posted on: April 19, 2024
Job Description:
Validation Engineer III, Equipment & CSVCatalent's Greenville,
N.C. facility specializes in end-to-end turn-key solutions for oral
solid dosage forms, including integrated formulation development,
analytical services, commercial manufacturing, and packaging. This
state-of-the-art facility has had over $100M of investments in
recent years and features fit-for-scale capacity with potent
handling capabilities, ideal for orphan or targeted drug
development.The PositionThe Validation Engineer III, Equipment &
CSV will provide direct validation support to pharmaceutical
development and manufacturing operations. Under little to no
supervision the Validation Engineer III, Equipment & CSV will
perform quality functions to ensure accurate execution and
documentation of all activities and projects as assigned. The
Role
- Author/Review executed equipment qualification protocols and
summary reports.
- Approve technical engineering and facility documents.
- Author/Review process validation protocols and validation
summary reports.
- Perform validation testing and analyze data for validation
documentation to determine acceptability, identify deviations and
make appropriate notification.
- Oversight and administration of site master validation
program.
- Update and maintain site validation master plan to align with
company and industry regulations.
- Lead validation projects in various disciplines, develop
strategy and timelines to deliver according to department and site
objective and goals.-- Work with project teams to meet project
milestones and deliverables to achieve OTD and RFT metrics.
- Assist in the implementation for improved site validation
activities and the quality systems related to these
activities.
- All other duties as assigned.The Candidate
- Bachelor's degree in a Technical or Life Sciences discipline
with at least 10 years of experience in the pharmaceutical industry
and at least 6 years in validation.
- Associate degree in a Technical or Life Sciences discipline
with at least 12 years of experience in the pharmaceutical industry
and at least 8 years in validation.
- In lieu of Technical/Life Sciences degree, a Bachelor's degree
with at least 8 years of experience in the pharmaceutical industry
and at least 4 years in the areas of Equipment/Facilities and
Computer Validation may be substituted.
- 4 years of recent experience in one or more of the following
areas: process validation, equipment validation, CFR 210 Part 11
software validation or cleaning validation - At least 3 years of
experience preparing and implementing validation protocols and
authoring validation summary reports.
- This position requires you to wear a respirator for your
safety, and as such, employment is contingent upon you being able
to complete a medical evaluation with satisfactory results prior to
the start of your employment.
- Some exposure to hazardous chemicals and other active chemical
ingredients.
- Position requires the capacity to handle and manipulate objects
using hands and arms.Why You Should Join Catalent--
- Several Employee Resource Groups focusing on D&I--
- Employee Stock Purchase Program--
- Tuition Reimbursement---- Let us help you finish your degree or
earn a new one!--
- Generous 401K match--
- 19 days accrued PTO + 8 paid holidaysCatalent offers rewarding
opportunities to further your career!-- Join the global drug
development and delivery leader and help us bring over 7,000
life-saving and life-enhancing products to patients around the
world. Catalent is an exciting and growing international company
where employees work directly with pharma, biopharma and consumer
health companies of all sizes to advance new medicines from early
development to clinical trials and to the market. Catalent produces
more than 70 billion doses per year, and each one will be used by
someone who is counting on us. Join us in making a
difference.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Greenville , Validation Engineer III, Equipment & CSV, Engineering , Greenville, North Carolina
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