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MES/Automation Engineer/Sr. Engineer
7 days ago
Automation Engineer
,
MES
–
Global MSAT
Just
- Evotec Biologics
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.
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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