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Engineering Services Lead - BioOpU

Company: Takeda Pharmaceutical
Location: Dracut
Posted on: November 24, 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 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 Engineering community.
    • 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 (Line) Expertise
      • 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 cross-functional issues
        • 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 business.Interaction
            • 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 practices.Innovation
              • Is capable of identifying latest trends in the industry like ASTM2500.
              • Is able to benchmark against peers in the industry
                • Provides inputs for defining the innovation roadmap in GMS CQV strategies
                • 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 areas
                    • Provides leadership to drive CQV standards that span multiple sites accross different demographics.
                      What you bring to Takeda : -Required
                      • 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 of expertise.
                        • High communication skills, analytical mind-set, ability to work under pressure
                        • 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, Lowell , Engineering Services Lead - BioOpU, Engineering , Dracut, Massachusetts

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