Associate MES Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

Legend Biotech · 2 weeks ago

Associate MES Engineer

Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Associate MES Engineer will be responsible for interfacing with MES end users to define change requirements and assist with electronic batch record development and administration to support production processing.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics
check
H1B Sponsor Likelynote

Responsibilities

Work with end users to define MES change requirements
Support eBR development, modeling, and deployment in MES
Participate in design testing, release planning, and demos with partners
Support MES updates with other Supply Chain Systems (ERP, eLIMs, etc.)
Support MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ)
Support updates to standardizations and documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures
Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections
Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization
This individual is responsible for collecting the necessary information and user requirements to ensure that the MES team properly assesses updates and impact

Qualification

MES (PAS-X)GMP environmentTechnical recommendationsCross-functional collaborationAnalytical skillsProblem solvingCritical thinkingCommunication skills

Required

A minimum of a Bachelor's degree in engineering or related field or equivalent experience required
A minimum of 3 years of relevant experience working in a GMP environment is required
Demonstrated experience working cross functionally with multiple departments translating business needs to change requirements
Working knowledge of MES application and user experience
Work cross functionally with stakeholders to clearly define business needs
Accurately and reliably gauge task effort and plan work to meet project timelines
Work closely with the MES and MSAT organization to ensure translation of changes from concept to implementation
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk
When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies
An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
Clear and succinct verbal and written communication skills

Preferred

Advanced degree preferred
Cell/Gene Therapy cGMP manufacturing and MES (PAS-X) experience preferred

Benefits

Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days
5 personal days
5 sick days
11 U.S. national holidays
3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs

Company

Legend Biotech

twittertwittertwitter
company-logo
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.

H1B Sponsorship

Legend Biotech 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
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)

Funding

Current Stage
Public Company
Total Funding
$750.45M
2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO

Leadership Team

leader-logo
Carlos Santos
Chief Financial Officer
linkedin
leader-logo
Alan Bash
President, CARVYKTI
linkedin
Company data provided by crunchbase