MS&T Engineer I/II jobs in United States
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Catalent · 1 week ago

MS&T Engineer I/II

positionMorrisville, NC
timeFull-time
remoteOnsite
seniorityMid, Senior Level
date4+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers. The MS&T Engineer I/II is responsible for providing technical support for clinical and commercial non-sterile drug product manufacturing, including tech transfers, process validation, and troubleshooting manufacturing processes.

BiotechnologyHealth CareManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Provides technical assistance for tech transfer and validation efforts for assigned manufacturing projects
Write Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc
Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed
Author manufacturing investigations and complete CAPA assignments
Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products
Interact with clients during routinely scheduled project meetings
Ensures timely completion and compliance with cGMP and all other relevant company training requirements

Qualification

Technical supportTech transferCGMP knowledgeProcess validationUS/EU regulationsDetail orientationVerbal communicationWritten communicationProblem solvingTime management

Required

Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field required
Minimum 4-6 years of experience of technical support and technical transfer in a non-sterile pharmaceutical manufacturing environment
Working knowledge of cGMP requirements related to non-sterile drug product manufacturing processes
Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required

Preferred

Working knowledge of US/EU regulations is preferred

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

GlobeNewswire
Global Cell and Gene Therapy Manufacturing QC Market Forecast to Achieve USD 2.01 Billion by 2031: Automation and Digitalization Revolutionizing the Landscape
2026-01-23
GlobeNewswire
Oncology Approvals Drive Demand for Specialized CDMO Capabilities Post-2025
2026-01-22
PR Newswire
Labaton Keller Sucharow LLP and Kessler Topaz Meltzer & Check, LLP Announce Pendency and Proposed Settlement of Class Action Involving Purchasers of Catalent, Inc. Securities
2026-01-20
Company data provided by crunchbase