MES/Automation Engineer/Sr. Engineer

7 days ago


Redmond, Washington, United States Evote Full time
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
MESdeployment and configuration as well as
MESintegration 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
MESfunctional domain solutions

and platform

for

JPOD
manufacturing

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

and other
MESworkflows for the
JPODmanufa

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
MESwith external systems such as process control systems (

DeltaV

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

MESsystem 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
MESsystem 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
MESexperience 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.

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