Senior Validation Engineer - Social Circle, United States - Takeda

Description

On the Global Manufacturing and Supply (GMS) team at Takeda, you'll be part of a rapidly transforming industry that's applying technology and data in new ways.

Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

Small Molecules
Biologics
Plasma
Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID

R

Date posted

05/13/2024

Location

Social Circle, Georgia
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


About the role:
Join Takeda as a Senior Validation Engineer where you will support site projects, technical transfers, and ongoing validation maintenance.

You will focus on the design, authorship, and execution of commissioning, qualification and validation studies for the following major disciplines and report to the Engineering Validation Manager at our location in Social Circle, GA.

Facilities, Utilities, and Equipment (FUE) qualification
Units operations automation qualification with Honeywell, Delta V, and PCL-based systems
Computerized systems validation
Process validation
You will provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs.

You must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of multiple factors or intangible variables.

How you will contribute:
Independently designs, authors, executes and summarizes commissioning, qualification and validation studies. Partner with SMEs to ensure efficient execution of testing strategies.
Collaboratively conduct risk and impact assessments.
Support development of standard operating procedures (SOP) and validation assessments.
Communicate with customers on technical issues, project timelines and validation support.
Participate on teams to determine the root-cause and corrective actions for problems associated with investigations.
Calculation and interpretation of data for commissioning, qualification and validation studies.
Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.
Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
Support operations and communications with Program Managers.
Exercise judgment within defined policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.

Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding capability.

Lead several small projects with complex features.
Serve on Tier 1 process teams.

What You Bring to Takeda:
Bachelor's degree in Engineering discipline required. Minimum 7 years validation experience for non-manager role; 5+ years experience for Supervisor.
7 years of relevant experience in a GMP regulated environment.
At least 4 years of commissioning, qualification and validation (CQV).
Validation and system experience in the following applicable areas:
Sterilization and aseptic processing validation.
Cleaning validation of manufacturing equipment.
Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
Protein purification from mammalian plasma and blood.
Technical experience with automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
Lead validation projects, coordinate contractors, and achieve results.
Direct manufacturing operations experience and biotechnology processes
Must work in a team environment, working with individuals at all levels in an organization and departmental areas.
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
Proficiency with Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
Excellent analytical skills with systematic approaches to solving problems. Can break down complex problems and tasks into manageable activities.
Must have basic knowledge of core principles in validation disciplines, and be experienced applying project management methodology.
Knowledge of basic principles in multiple engineering disciplines.
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:
May work weekends, evenings, off-hours, extended periods of time.
Occasionally, may lift up to 50 pounds.
Need to gown and operate in an environment requiring gowning.
Up to 10% travel expected.

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.
Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.

#GMSGQ
#ZR1
#LI-MA1
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 - GA - Social Circle - Hwy 278

U

S Base Salary Range:
$84, $132,000.00

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


About the role:
Join Takeda as a Senior Validation Engineer where you will support site projects, technical transfers, and ongoing validation maintenance.

You will focus on the design, authorship, and execution of commissioning, qualification and validation studies for the following major disciplines and report to the Engineering Validation Manager at our location in Social Circle, GA.

Facilities, Utilities, and Equipment (FUE) qualification
Units operations automation qualification with Honeywell, Delta V, and PCL-based systems
Computerized systems validation
Cleaning validation
Sterilization validation
Materials validation
Process validation
You will provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs.

You must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of multiple factors or intangible variables.

How you will contribute:
Independently designs, authors, executes and summarizes commissioning, qualification and validation studies. Partner with SMEs to ensure efficient execution of testing strategies.
Collaboratively conduct risk and impact assessments.
Support development of standard operating procedures (SOP) and validation assessments.
Communicate with customers on technical issues, project timelines and validation support.
Participate on teams to determine the root-cause and corrective actions for problems associated with investigations.
Calculation and interpretation of data for commissioning, qualification and validation studies.
Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.
Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
Support operations and communications with Program Managers.
Exercise judgment within defined policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.

Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding capability.

Lead several small projects with complex features.
Serve on Tier 1 process teams.

What You Bring to Takeda:
Bachelor's degree in Engineering discipline required. Minimum 7 years validation experience for non-manager role; 5+ years experience for Supervisor.
7 years of relevant experience in a GMP regulated environment.
At least 4 years of commissioning, qualification and validation (CQV).
Validation and system experience in the following applicable areas:
Sterilization and aseptic processing validation.
Cleaning validation of manufacturing equipment.
Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
Protein purification from mammalian plasma and blood.
Technical experience with automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
Lead validation projects, coordinate contractors, and achieve results.
Direct manufacturing operations experience and biotechnology processes
Must work in a team environment, working with individuals at all levels in an organization and departmental areas.
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
Proficiency with Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
Excellent analytical skills with systematic approaches to solving problems. Can break down complex problems and tasks into manageable activities.
Must have basic knowledge of core principles in validation disciplines, and be experienced applying project management methodology.
Knowledge of basic principles in multiple engineering disciplines.
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:
May work weekends, evenings, off-hours, extended periods of time.
Occasionally, may lift up to 50 pounds.
Need to gown and operate in an environment requiring gowning.
Up to 10% travel expected.

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.
Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.

#GMSGQ
#ZR1
#LI-MA1
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 - GA - Social Circle - Hwy 278

U

S Base Salary Range:
$84, $132,000.00

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

e

mployee

s

may be eligible for

s

hort

t

erm and/

or

l

ong-

t

erm

incentive

s

.

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 - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation

Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

Top Workplace
Top Workplace

Recognized for our culture and way of working, we're one of only 17 companies to receive Top Global Employer status for 2024.

Work-Life
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity
Perseverance
We're Steadfast In Our Commitment to

Four Key Imperatives

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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