Automations Engineer (RTU)
Company: Cameron Craig Group
Posted on: October 21, 2019
The Automation Engineer's primary role is to support Manufacturing
and Operations by providing technical support and troubleshooting
day to day automation issues within a cGMP production environment.
This position will play a key role in all stages of the engineering
project and equipment lifecycle from conceptual design, detailed
design, specification, implementation, commissioning, trouble-
shooting, and continuous improvement of automation and
instrumentation for pharmaceutical production and supporting
utility systems. The Automation Engineer will be the primary
interface with the automation integrator for project SUN
The Automation Engineer will coordinate with functional peers to
define issues, develop and document solutions to complex problems,
and communicate updates and performance back to peers and
Strong organizational and teamwork skills required to be successful
in a dynamic environment with changing priorities.
Present and document control system project proposals, change
management, system specifications and other technical documents,
demonstrating strong written and verbal communication skills.
Diagnose and solve moderate to complex automation problems to
support 24/7 manufacturing activities.
Ensure compliance with company policies, Standard Operating
Procedures (SOPs) and cGMP requirements.
Recommend new technologies and implement modern controls
architectures in line with current trends in GMP's and automation
and instrumentation technology.
Develop options assessments and recommend best course of actions
based on data.
Demonstrated project delivery, with ability to represent control
system engineering design, construction and validation practices to
Uses operational excellence and lean methodology to generate
pragmatic, innovative and robust solutions.
Apply traditional engineering project stages from origination
through closure and rely on thorough options analysis to make
Establishes rapport, builds relationships that create networks with
those individuals and stakeholder groups critical to short and long
term goal attainment.
Continuously aligns on expectations through on-going communication
and open access to critical information.
Proficiency with Microsoft products and the desire to learn
additional software applications as required.
Carry Company supplied mobile device for emergency on-call 24 hour
support as required.
Objectively analyze data and align expectations to bring definition
to projects that have loosely defined objectives.
Work across functions and disciplines to collect and analyze data
to improve the compliance and efficiency of manufacturing
Identify and manage small projects involving multiple functions and
disciplines within the organization.
Good understanding of industry standards and practices related to
controls software design and commissioning.
Partner with Quality to ensure processes and products are in
compliance with all local, state, and federal rules and
regulations.---- Oversee that processes are in CGMP compliance, and
establish systems that identifies opportunities for improvement and
makes constructive suggestions for change to improve process
effectiveness to heighten quality. Develop knowledge of and
understand regulatory requirements such as 21CFR part 210 and 211,
cGMP's, FDA, OSHA and other regulatory agencies.
Personnel engaged in the manufacture, processing, packing, or
holding of a drug product shall wear clean clothing appropriate for
the duties they perform. Protective apparel, such as head, face,
hand, and arm coverings,--shall--be worn as necessary to protect
drug products from contamination.
Bachelor's degree in Electrical Engineering, Engineering Sciences
or, Associate Degree in Electrical Engineering with appropriate
industrial controls experience.
Minimum 3 years BMS, PLC, SCADA, Manufacturing Databases,
instrumentation configuration, programming, and design in a cGMP
Experience with Allen Bradley PLC platforms as well as Siemens BMS
systems, SCADA systems, PI Historian, iFix, iHistorian, Industrial
Ethernet networks, ControlNet networks.
Familiarity with batch and continuous processes within the
Pharmaceutical Industry is preferred.
Knowledge of GAMP 5 preferred
Experience with S88 and ISA standards would be an advantage.
Advanced GxP Data Acquisition and reporting.
Physical Requirements of the Role
This role is continuously sitting and typing.-- Frequently talking
and using eye and hand coordination.-- Occasionally requiring
lifting and carrying less than 25 lbs. Standing, walking, bending
over, and repetitive use of legs are done occasionally.
Position is exposed to plant environment.-- Any person shown at any
time (either by medical examination or supervisory observation) to
have an apparent illness or open lesions that may adversely affect
the safety or quality of drug products--shall--be excluded from
direct contact with components, drug product containers, closures,
in-process materials, and drug products until the condition is
corrected or determined by competent medical personnel not to
jeopardize the safety or quality of drug products. All
personnel--shall--be instructed to report to supervisory personnel
any health conditions that may have an adverse effect on drug
Keywords: Cameron Craig Group, Lorain , Automations Engineer (RTU), Engineering , Cleveland, Ohio
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