Process Validation Engineer jobs in United States
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Catalent · 3 weeks ago

Process Validation Engineer

positionGreenville, NC
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
date2+ years exp

Catalent is a leading global drug development and delivery company specializing in oral solid dosage forms. The Process Validation Engineer will provide validation support to pharmaceutical development and manufacturing operations, ensuring compliance and quality in all validation documentation and processes.

BiotechnologyHealth CareManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Collaborate with the Cleaning Verification and Validation Analytical Group to develop draft cleaning verification and validation protocols
Review cleaning validation protocols, residue limits, reports, and cleaning verification/validation summary packages
Evaluate the impact of planned and unplanned changes to formulations, processes, or equipment on cleaning validation status
Author and review equipment and utilities qualification protocols and summary reports
Review executed qualification protocols and summary reports for completeness, accuracy, and compliance
Assist with the execution of equipment and utilities qualification activities as required
Ensure validation documentation is archived in accordance with GMP documentation retention requirements
Other duties assigned

Qualification

Process validationCleaning validationPharmaceutical industry experienceEquipment qualificationTechnicalLife Sciences degreeDynamic pacePersonal initiative

Required

Bachelor's degree in a Technical or Life Sciences discipline with 2+ years of experience in the pharmaceutical industry; or Associate degree in a Technical or Life Sciences discipline with 4+ years of experience in the pharmaceutical industry required
1+ year of validation experience required
Position requires the capacity to handle and manipulate objects using hands and arms

Preferred

Oral solid dosage (OSD) experience preferred
Process validation experience strongly preferred
Experience in a Catalent production role with a demonstrated solid understanding of internal manufacturing processes may be considered in lieu of direct validation experience

Benefits

Competitive medical benefits and 401K
152 hours PTO + 8 Paid Holidays

Company

Catalent

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Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
dateFounded in 2007
location
Tampa, Florida, USA
people-size10001+ employees
web-link
https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)

Funding

Current Stage
Late Stage
Total Funding
unknown
2021-01-06Acquired

Leadership Team

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Alessandro Maselli
President & Chief Executive Officer
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Charles Lickfold
Senior Vice President, Chief Information Officer
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Recent News

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PR Newswire
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2026-01-20
Company data provided by crunchbase