Senior Automation Engineer MES
Company: Takeda Pharmaceutical
Location: Los Angeles
Posted on: April 17, 2024
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Job Description:
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Job Description
About the role
You will manage the automation strategy, implementation plan,
software development, and systems integration, specializing in
Electronic Batch Management (EBM) / Manufacturing Execution System
(MES). Be a site EBM Subject Matter Expert (SME) and collaborate
with Global / Local MES and Automation technical teams to ensure
agreement and fulfill strategic objectives. Exhibits creativity and
progress in completing divisional and department responsibilities.
Utilize technical expertise to manage high-visibility projects and
resolve complex issues. Analyze business processes, evaluate, and
design/redesign procedures to meet user requirements. Provide
guidance and direction to Takeda employees and contractors to meet
schedule and financial goals while ensuring technical success. Lead
scope definition, conceptual design, specifications, budgeting,
scheduling, commissioning, and production support. Provide
guidance, review, and direction to create functional Life Cycle and
other documentation per cGMPs and Takeda Quality Systems
standards.
How you will contribute
Lead large-scale programs, and multiple small projects with complex
features.
Plan and schedule project implementation.
Define the scope of work for the project team, commissioning, and
validation support.
Perform financial planning and assist in the analysis to justify
project approval.
Review proposals to determine if benefits derived and possible
applications justify expenditures.
Coordinate status, solutions, and opportunities with other
departments to ensure successful implementation of the design.
Understand appropriate SDLC, SOPs, quality validation processes,
and regulatory requirements for all system update actions.
Lead the EBM system code development and for multiple scale level
projects.
Gather, understand, and document business user requirements,
including overall objectives and process specifications.
Align requirements with software and system capabilities and
provide business partners with solutions.
Develop test cases, scripts, and protocols that sufficiently
document understanding between code and business requirements.
Maintain all system functional and design specifications according
to quality system procedure and regulatory requirements.
Provide guidance and training on MES system procedures and
standards to internal and external team members.
Solve MES system issues that result in product impact and
production delays; coordinate and contact support groups for
assistance. This support will include CAPA investigation
involvement and task ownership. Recommend and implement actions to
prevent recurrence. Manage and oversee Trackwise Project Records
associated with system requirements resulting from investigations
or issues.
What you bring to Takeda
Bachelor's degree in engineering discipline required.Computer,
Chemical, Mechanical, Electrical Engineering Degree Preferred.3+
years of related experience. Some leadership experience preferred
for supervisory roles.
Experience managing MES systems in an FDA regulated manufacturing
settings.
Knowledge of GMPs, FDA guidelines and validation.
Maintain industry contracts and be involved in industry interest
groups.
3+ years of experience in process design, controls engineering and
process improvement.
Knowledge of MES (Siemens Opcenter Execution Pharma).
Important Considerations
Must be able to lift, push, pull and carry up to 25 lbs.
In general, your work will be a combination of sedentary work and
walking around observing conditions in the facility.
Will work in controlled environments requiring special gowning.
Will follow gowning requirements and wear protective clothing over
the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial
fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment.
Must be able to work multiple shifts, including weekends.
May work in a confined area.
Some Clean Room and cool/hot storage conditions.
Will work in demolition/construction area.
Must be able to work 100% onsite.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider
the next step in your career. We are committed to equitable pay for
all employees, and we strive to be more transparent with our pay
practices.
For Location:
USA - CA - Los AngelesU.S. Base Salary Range:
$84,000.00 - $132,000.00The estimated salary range reflects an
anticipated range for this position. The actual base salary offered
may depend on a variety of factors, including the qualifications of
the individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job. The actual base salary offered will be
in accordance with state or local minimum wage requirements for the
job location.
U.S. based employees may be eligible for short-term and/or
long-termincentives. U.S.based employees may be eligible to
participate in medical, dental, vision insurance, a 401(k) plan and
company match, short-term and long-term disability coverage, basic
life insurance, a tuition reimbursement program, paid volunteer
time off, company holidays, and well-being benefits, among others.
U.S.based employees are also eligible to receive, per calendar
year, up to 80 hours of sick time, and new hires are eligible to
accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Locations
USA - CA - Los AngelesWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time--s-p-m1--
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Keywords: Takeda Pharmaceutical, Newport Beach , Senior Automation Engineer MES, Engineering , Los Angeles, California
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