Senior Validation Engineer

Company: Takeda Pharmaceutical
Location: Lancaster
Posted on: May 13, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line 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
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