Engineering Services Lead - BioOpU
Company: Takeda Pharmaceutical
Posted on: November 14, 2022
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application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout the role :
- Provide specialist expertise to ensure manufacturing plants use
a consistent approach to CQV.
- Ensure CQV approach is aligned with industry norms and Global
Quality expectations. -How you will contribute :
- Lead and drive the overall CQV program for the OpU/Region to
ensure consistent approach to ASTM2500, and individual Site CQV
programs are consistent across sites.
- Drive key site CQV projects around tech transfer, process
improvements and asset recapitalization.
- Drive regulatory inspection readiness & responses from the Site
- Lead COP's and consistency on Site operation procedures.
- Ensure consistency on Site Validation master plans and
requalification programs in line with global programs.
- Develop & nurture core competencies of CQV SMEs at sites to
ensure technical capabilities are built and that knowledge and
experience is maintained.
- -Manage contractors and external vendors to deliver capable
resources to perform CQV to Takeda standards.Technical/Functional
- Must be able to display indepth knowledge and expertise in CQV
methodolgy including computer systems validation.
- Displays strong problem solving capabilities.
- Can display analytical and conceptual thinking
- Has a deep and broad understanding of pharmaceutical
manufacturing process, regulatory environment, trends in CQV
especially around ASTM2500, and financial acumenLeadership
- An enterprise leader balancing and aligning goals and
priorities to meet company objectives
- Ability to influence within the organization to drive
decisions, alignment, and conflict resolution for complex
- Being a mentor developing future leaders
- Displays and drives Takeda culture of Takeda-ism, PTRB, safety,
and quality into the organizationDecision-making and Autonomy
- Full accountability for decisions regarding CQV masterplans &
standards, organization capability and delivery of value to the
- Is able to easily engage with both internal and external
stakeholders to drive performance and rollout CQV standard.
- Collaborate across all technologies including Plasma,
Biologics, API and Small Molecule within GMS to align on CQV
standard operating procedures.
- Works across Site teams to align and implement CQV best
- Is capable of identifying latest trends in the industry like
- Is able to benchmark against peers in the industry
- Provides inputs for defining the innovation roadmap in GMS CQV
- Ensures process knowledge sharing across sites and GE functions
for effective development of organizational capabilities.Complexity
- Manages with a matrix of reporting lines and across functional
- Provides leadership to drive CQV standards that span multiple
sites accross different demographics.What you bring to Takeda :
- Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or
equivalent (mechanical / process / chemical or equivalent
- Languages: Business fluent proficiency in English & Local
Language (written and oral) ,
- Experience: More than 8 years experience in GMP manufacturing
relevant to the specialist area of expertise.
- Minimum of 5 years leadership experience
- Broad knowledge of CQV methodology and best practice in field
- High communication skills, analytical mind-set, ability to work
- GxP/QA knowledge
- Innovative thinking
- Building relationships and teamwork
- Used to working in a complex global / matrix organisation.
- Can establish and coordinate service contracts with external
service providersAdditional desired Skills:
- Experience with data analysis
- Good understanding of the pharmaceutical industry not limited
to technical aspects onlyTravel requirementsRegular travels to
Takeda sites within the region and to equipment and service
providers. (Approx. 25% travel)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.Empowering our people
to shine: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 religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status -or
any other characteristic protected by law. -LocationsZurich,
SwitzerlandUSA - MA - Lexington - BIO OPSWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Weymouth , Engineering Services Lead - BioOpU, Other , Weymouth, Massachusetts
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