Senior Quality Validation Engineer
Company: Takeda
Location: Libertyville
Posted on: July 8, 2025
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Job Description:
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with Takeda’s Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description About the role: The
Senior Quality Validation Engineer is in the Validation Quality
organization at the Takeda Round Lake aseptic pharmaceutical
manufacturing facility. You will work as part of teams providing
quality oversight and approval of change control and validation
deliverables to ensure that products and processes meet with
appropriate regulatory agency validation requirements, internal
company standards and current industry practices. This employee
will typically focus on disciplines related to equipment, cleaning,
process, control system and computer system validations. You will
report to the Quality Validation Manager. How you will contribute:
Quality Systems/Document Control: Owns Standard Operating
Procedures and other Quality System Documentation relevant to their
area of expertise. Approve Standard Operating Procedures and other
Quality System Documentation relevant to all areas of the plant.
Training: Develops and delivers training materials relevant to area
of expertise. Approve training materials relevant to all areas of
the plant. Validation Quality: Participates as a team member in the
execution and documentation of Validation Master Plans, Design
Qualification, Installation Qualification, Operational
Qualification, Performance Qualification, Computer System
Validation, and Validation Maintenance packages following existing
procedures. Review deliverables for compliance to existing
requirements. Approve validation documentation (e.g., protocols,
CWRs, or risk assessments) that establishes novel requirements or
assesses risk. Risk Management: Leads teams in the execution of
risk management activities. Deviations and CAPA: Owns
investigations and CAPAs relevant to responsibilities/expertise.
Approve investigations and CAPAs relevant to all areas of the
plant. Change Control: Approves change controls for compliance to
existing requirements. Quality Leadership: Leads Quality project
teams and present to Plant management project plans, progress, and
risks. Represent us in areas of expertise to governmental
Regulatory bodies. Requirements: Proficiency in writing and
approving change control and risk assessments processes. Experience
applying cGMPs. Knowledge of validation principles across multiple
disciplines including equipment, facilities, computerized systems
and laboratory equipment. Stakeholder management skills to manage
all partners that support the site. Excellent
influencing/collaboration skills and teamwork mindset. Experience
presenting to inspection auditors. Knowledge of descriptive
statistics. Working knowledge of inferential statistics and related
techniques (e.g., sample size determination, comparison analysis,
ANOVA, DoE). Complete assigned training. Identifies, escalates,
and/or resolves potential compliance and/or safety issues. What you
bring to Takeda: Bachelor's degree in science, engineering or other
related technical field. 4 years of related experience. Important
Considerations At Takeda, our patients rely on us to deliver
quality products. As a result, we must follow strict rules in our
manufacturing facilities to ensure we are not endangering the
quality of the product. You may: You must not be allergic to
Cephalosporin drugs. May work in a controlled environment requiring
special gowning and wear protective clothing over the head, face,
hands, feet and body. This may include additional hearing
protection for loud areas. Will need to remove all make-up,
jewelry, contact lenses, nail polish and artificial fingernails
while in the manufacturing environment. May work in a cold, hot or
wet environment. May work around chemicals such as alcohol, acids,
buffers and Celite that may require respiratory protection. Will
work nights, weekends, and holidays to support manufacturing when
needed. More about us: At Takeda, we are transforming patient care
through the development of novel specialty pharmaceuticals and the
best patient support programs. Takeda is a patient-focused company
to inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating
careers, encourages innovation, and strives for excellence in
everything we do. We foster an inclusive, collaborative workplace,
in which our teams are united by an unwavering commitment to
deliver Better Health and a Brighter Future to people around the
world. GMSGQ ZR1 LI-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 - IL - Round Lake Innovation Park U.S.
Base Salary Range: $86,500.00 - $135,960.00 The 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 - IL - Round Lake
Innovation ParkUSA - IL - Round Lake - Drug Delivery Worker Type
Employee Worker Sub-Type Regular Time Type Full time Job Exempt
Yes
Keywords: Takeda, Crystal Lake , Senior Quality Validation Engineer, Science, Research & Development , Libertyville, Illinois