Senior Cleaning Validation Specialist
Company: Disability Solutions
Location: Saint Petersburg
Posted on: October 23, 2024
Job Description:
Senior Cleaning Validation Specialist Position SummaryCatalent
is a global, high-growth, public company, and a leading partner for
the pharmaceutical industry in the development and manufacturing of
new treatments for patients worldwide. Your talents, ideas, and
passion are essential to our mission: to help people live better,
healthier lives.Catalent's St. Petersburg is our primary softgel
development and manufacturing facility in North America with a
capacity of 18 billion capsules per year. --The featured RP Scherer
softgel technology is a proven oral drug delivery solution to
enhance bioavailability of poorly soluble Rx and OTC drug
candidates. --Non-gelatin based OptiShell-- and Vegicaps-- capsules
expand the range of molecules into softgel, ideal for challenging
fill formulation.--Within the Catalent network, we offer a broad
range of integrated formulation and analytical services to solve
your most difficult development and manufacturing challengesThe
Senior Cleaning Validation Specialist position involves creating
cleaning cycle development strategies for a variety of equipment
including process vessels, clean-in place systems, and parts
washers.-- The Senior Cleaning Validation Specialist also
responsible for supporting the design, execution and closure of
cleaning studies associated with equipment used in the manufacture
of drug product intended for human consumption. This validation
group within the Quality Assurance department oversees all aspects
of validation as they relate to the implementation of relevant
projects and their potential impact on product quality and
GMP/GLP.-- The validation department is responsible for ensuring
that all facilities, processes, equipment/systems and automated
equipment used for GMP/GLP critical purposes are validated and
remain in a validated state.Catalent is committed to a Patient
First culture through excellence in quality and compliance, and to
the safety of every patient, consumer and Catalent employee.--The
Role
- Review and revision of existing cleaning processes to identify
improvements. Development of cleaning cycles for process vessels,
clean-in-place systems, and part washers.
- In conjunction with product development develop procedure for
determining solubilities of new APIs in different solvents to
support development of appropriate cleaning cycles. Identification
and on-boarding of alternate detergents.
- Development of cleaning batch records or cleaning checklists to
be used to document cleanings were performed according to
procedures.
- Updating of production procedures, as necessary, to reflect the
developed cleaning cycles. Support the design, execution and
conclusion of studies that pertain to cleaning verifications /
validations.--
- Coordinate all validation activities with internal departments,
while providing customer service and support to the manufacturing
process.
- Author validation documentation including, but not limited to,
Cycle Development Protocols / Reports / Procedures, Cleaning
Verification / Validation protocols and reports, Cleaning
Assessments and Matrices, and Protocol Discrepancies and
Addenda.
- Other duties as assigned.The Candidate
- Bachelor's degree in Science or Engineering required.
- 5+ years' experience in the pharmaceutical industry performing
cleaning cycle development and validation required.
- Strong written and oral communication skills required.
- Knowledge of pharmaceutical manufacturing processes and cGMP
required.
- Familiar with Microsoft Word and Excel.
- Ability to solve problems with little guidance.-- Ability to
identify most efficient method in order to achieve predetermined
objective.-- Ability to work effectively under pressure with
constantly changing priorities and deadlines. Individual may be
required to sit, stand, walk regularly and occasionally lift to 15
lbs; no lifting greater than 44.09 pounds without assistance.--
Specific vision requirements include reading of written documents
and use of computer monitor screen frequently. Ability to work
extended hours or off-hours as required.Why You Should Join
Catalent
- Tuition Reimbursement - Let us help you finish your degree or
earn a new one!
- WellHub program to promote overall physical wellness.
- 152 hours of PTO + 8 paid holidays.
- Medical, dental and vision benefits effective day one of
employment.
- Defined career path and annual performance review and feedback
process.
- Diverse, inclusive culture. Several Employee Resource Groups
focusing on D&I. Community engagement and green
initiatives.
- Dynamic, fast-paced work environment.
- Positive working environment focusing on continually improving
processes to remain innovative.
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives.
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categories.Catalent
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.--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, Bonita Springs , Senior Cleaning Validation Specialist, Other , Saint Petersburg, Florida
Didn't find what you're looking for? Search again!
Loading more jobs...