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Senior Automation Engineer, MES

4 months ago


Redmond, United States Evotec WD Full time

Senior Automation Engineer, MES page is loaded

Senior Automation Engineer, MES

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locations

Redmond

time type

Full time

posted on

Posted 7 Days Ago

job requisition id

JOB ID-09579

Senior

Automation Engineer

, MES



Global MSAT Just

-Evotec Biologics

is

seeking

a motivated and creative Senior

Automation

Engineer

,

MES

that

desires

a significant opportunity to improve worldwide access to biotherapeutics

.

The

Sr. E

ngineer will be part of the

Automation Team in Global MSAT

that

is

responsible for

defining the

MES

standards for the J.POD Manufacturing platform and ensuring alignment across the J.POD network, as well as provide

MES

automation

support

to Just-Evotec’s manufacturing sites.

The successful candidate will have demonstrated proficiency in MES deployment and configuration as well as MES integration with related business and automation systems such as Level 4/ERP and Level 2/PCS.

Experience with biologics manufacturing processes in a GMP environment, change control, and software validation in accordance

to

GAMP5 guidelines is highly preferred

. Responsibilities (including but are not limited to): Collaborate with key stakeholders and provide input and guidance in

identifying

and implementing MES functional domain solutions

and platform

for

JPOD

manufacturing

Translate process requirements and MES system best practices into practical, usable electronic batch records (MBR recipe design)

and other MES workflows for the JPOD manufa

cturing

platform

Maintain global validated

MES

library

and

participate

in

d

efin

ing

the governance

and global change management for the

MES

platform to

ma

intain

alignment across the

JPOD

manufacturing

network

Apply risk-based approach to develop design requirements and support computer system validation

strategy

Lead or support integration

strategy

of MES with external systems such as process control systems (

DeltaV

), lab equipment and instruments, and other electronic systems (ERP, LIMS, etc.)

MES system configuration, programming, testing, and troubleshooting

Author design documents (configuration, software design specifications) and validation protocols

Lead execution of test scripts

Develop business processes, guidelines, SOPs, and training for the MES

system

Support MES system life cycle, expansion strategy, and business/technical process change

management

Participate in

engagement with Site MSAT teams

to support

global and site

objectives

Participate in internal and external audits/

inspections

Position Requirements: B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.

5+ years of MES experience in Pharmaceutical, Biotech, or Life Sciences industries

with

5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations

Working knowledge of cGMP manufacturing and regulatory regulations and requirements for

biologics/pharmaceuticals

Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards

Knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.)

Demonstrated ability to work independently and collaboratively on cross-functional teams.

Additional Preferred Qualifications: Previous experience in computer software validation coordinating activities with IT, QA, Warehouse, and Manufacturing

Leverage expertise using GAMP5 guidelines for risk-based approach to computer system validation

Applies knowledge and expertise to solve complex technical problems

Authority inspection or audit support involvement

Experience with a manufacturing process that utilizes single-use technologies and systems

Experience using DeltaV

Experience using PAS-X

Proficiency developing and executing CSV plans and protocols

The base pay range for this position at commencement of employment is expected to be $92,800 to $152, 425; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

About Us

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com

and follow us on X/Twitter @Evotec

and LinkedIn . Please click on the link below to access and review our Privacy Information for Applicants:

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