Senior Validation Engineer
Company: Takeda Pharmaceutical
Location: Lancaster
Posted on: May 13, 2022
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Job Description:
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Job Description
Senior Validation Engineer
Takeda Pharmaceutical Lexington, MA
About the role: Join Takeda as a Senior Validation Engineer where
you will identify opportunities for continuous improvement, deploy
best practices, update validation programs to reflect current
regulations and trends. You will also lead partner audits and
regulatory agency inspections for Validation along with author and
review responses to inspection observations and questions . As part
of the Validation Engineer team, you will report to the Validation
Manager and work with several groups and team within the
facility.
How you will contribute: You will write and implement validation
activities for Facilities, Equipment, Shipping / Cold Chain,
Process, Cleaning, Steaming / Autoclave, Computer systems, Plant
Automation, Validation Maintenance and Validation document control
and archival program
You will develop and assess the Quality system elements for
Validation including Quality Risk Management program, CAPA's,
Change Controls, Deviations and GMP Investigations
You will represent validation during tech transfers and lead
cleaning and process validation efforts
You will provide technical input to strategies for process and
cleaning validation
You will manage complex validation and technical projects
What you bring to Takeda: Bachelor's degree in a technical
discipline (Engineering or Biological Sciences) with 5 or more
years pharmaceutical or biopharmaceutical industry experience
Leadership experience with demonstrated effectiveness in developing
validation strategy, leading complex validation projects and
developing personnel
Comprehensive knowledge of global cGMP requirements and
expectations (US, EU, Japan, ICH, PIC/S, WHO)
Experience working projects individually and with team members
Experience to analyze data, measure risks, identify gaps, and
implement corrective actions to increase efficiency and improve
compliance.
What Takeda can offer you: Comprehensive Healthcare: Medical,
Dental, and Vision
Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health
screenings
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement
More about us: At Takeda, we are transforming patient care through
the development of novel specialty pharmaceuticals and best in
class patient support programs. Takeda is a patient-focused company
that will 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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
#GMSGQ
#ZR1
#LI-MA1
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 - MA - Lexington - BIO OPS
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Worcester , Senior Validation Engineer, Engineering , Lancaster, Massachusetts
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