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Sr. Commissioning Engineer
2 weeks ago
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Hitachi Energy Ltd. Oakland, United StatesLocation: · Oakland, California, United States · Job ID: · R0043074 · Date Posted: · Company Name: · HITACHI RAIL STS USA, INC. · Profession (Job Category): · Other · Job Schedule: · Full time · Remote: · No · Job Description: · Hitachi Rail is looking for an enthusiastic self-mo ...
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Hitachi Automotive Systems Americas Oakland, United StatesSenior Wayside Signalling Test and Commissioning Engineer page is loaded · Senior Wayside Signalling Test and Commissioning Engineer · Apply · locations · Oakland, California, United States · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R ...
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Hitachi Data Systems Oakland, United StatesPrincipal Wayside Signaling Test and Commissioning Engineer · Location: Oakland,California,United States · Job ID: · R0043071 · Date Posted: · Apr 10, 2024 · Segment: · Green Energy & Mobility · Business Unit: · Hitachi Rail · Company Name: · HITACHI RAIL STS USA, INC. · Pr ...
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Hitachi Data Systems Oakland, United StatesSenior Wayside Signalling Test and Commissioning Engineer · Location: Oakland,California,United States · Job ID: · R0043074 · Date Posted: · Apr 10, 2024 · Segment: · Green Energy & Mobility · Business Unit: · Hitachi Rail · Company Name: · HITACHI RAIL STS USA, INC. · Prof ...
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Start-Up and Commissioning Lead Engineer I
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Blentech Corporation Santa Rosa, United StatesJob Title: Start-Up and Commissioning Lead Engineer I · Reports to: Chief Technical Officer · SUMMARY · Blentech Corporation, in Santa Rosa, CA seeks a Start-Up and Commissioning Lead Engineer I to function as the primary contact and project coordinator between Blentech custom ...
Commissioning Engineer 2 - Novato, United States - Biomarin
Description
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Come join our team and make a meaningful impact on patients' lives.SUMMARY
This position is responsible for
facilities, utilities and
equipment commissioning and qualification project activities in
both
cG
x
P
and non-
cG
x
P
environment
s
.
This position will interface with key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control,
Global
Quality Assurance, Validation and Manufacturing.
The position organizes and performs commissioning and qualification activities with minimal supervision within a cross-functional environment.
Other responsibilities of this position
include:
project managemen
t,
contractor management,
document reviews,
project plan generation,
protocol generation, protocol execution,
data analysis, report generation
,
contractor
training, and
other duties as assigned.
This position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.
RESPONSIBILITIES
Generate, e
xecute
and review protocols and reports for
facility
, utility and equipment
commissioning and qualification activities related to the implementation of system changes and new systems, while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet BioMarin and
Health Authority
requirements.
Coordinate commissioning and qualification activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Quality Control, Quality Assurance, Quality Validation, Capital Projects, Facilities and various Engineering groups.
Develop C&Q
P
roject p
lans for
large
capital projects.
Develop Requests for Proposals for contract resources and train contract resources on BioMarin procedures.
Demonstrate leadership ability including the ability to lead, motivate, develop and directly/indirectly influence others effectively
Employ good document practices
(GDP) when
drafting and reviewing documents executing protocols,
recording data, and
generating reports
Creates and Develops SOP's and Best Practices in support of
risk-based
verification and qualification.
(ASTM E2500
, ISPE and Health Authority guidelines
)
Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Generation of Testing Trace Matrices and Design Matrices along with additional supporting documentation.
Apply extensive practical expertise in their area(s) of knowledge
Effectively manage internal and external relationships with key stakeholders and vendors
Develop and maintain effective communication with peers, subordinates and senior management
Demonstrate the ability to be self-directed with limited guidance and oversight from management
Effectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidance
Demonstrate effective collaboration, partnering and teamwork skills when interacting with internal and external resources
Actively participate in technical, tactical and strategic reviews/discussions
Remain current on all training requirements
SCOPE
This position provides support to Global Projects and Engineering by developing and implementing C & Q strategies, oversee and manage the commissioning and qualification of large capital projects and collaboratively develop our C & Q policies and practices for the Global engineering group.
EDUCATION
BS or MS in Mechanical, Electrical, Chemical Engineering or a biological science from an accredited university.
Relevant job and years of experience may be substituted in place of a degree.
EXPERIENCE
6
years experience
in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in commissioning, qualification, procedure generation and change control.
2years experience
with Automation commissioning and qualification
.
1years experience
in a position utilizing formal project management a plus.
Organizational and management skills to coordinate multi-discipline project groups
Ability to speak, present data, and defend approaches in front of audiences and inspectors.
Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections a plus
Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for qualification expectations a plus.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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