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Principal Engineer, Material Qualification/Validation

応募後で応募 求人ID R0037147 掲載日 06/15/2021 Location:Lexington, Massachusetts

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Job Description

Primary Duties

  • The Principal Engineer, Material Qualification/Validation in Material Qualification group will play a key role in establishing and ensuring material qualifcation compliance for single use bioprocess systems and raw materials.
  • Lead development of material control strategies through development/execution of MQ protocols, reports and other documentation for single use components and QC released raw materials within all manufacturing processes.
  • Be a single use and raw materials subject matter expert and a recognized expert in the area of single-use systems, raw materials, material sciences or other related field.
  • Establish material qualification expertise for MA Bio Ops by maintaining material qualification systems.
  • A subject matter expert in single use material L&E assessment. Work with process and data analytics team to build and maintain a single use material data base, including single use component info as well as leachable and extractable data.
  • Own, support and facilitate changes and improvements through quality systems such as Change Controls, Corrective and Preventative Actions (CAPAs), Supplier Notifications of Change, Engineering Change Management Develop MQ validation packages, including acquisition of necessary data, are incorporated into final reports.
  • Ensure technical assessments on change controls, deviations and investigations are provided, assessing proposed changes to qualified materials to identify requirements necessary to maintain qualified status.
  • Represent MQ on project core teams and participate in strategy discussions on behalf of MQ in collaboration with Manufacturing Sciences team and aligned with regulatory requirements.
  • Support strategy development for tech transfers and new product introductions for the qualification of new chemical and single use raw materials.
  • Interface with other site functions including procurement and process development to effectively communicate requirements for material qualification and ensure they are a part of routine site business processes.
  • Develop/manage raw material characterization program to establish impact of complex raw material variability (such as Serum, media, hydrolysate) on process yields and engage with vendors to establish a complex raw material database
  • Influence internal functions (cross functional depts) and external partners (e.g. BPOG/BPSA) to establish best practice for single use and other raw materials        

Responsibilities: Job Function and Description

Percentage of Time:

10%

  • This is a independent contributor role with crossfunctional leadership responsibilities. Expected to be a coach for a small team to be material qualification expert for single use systems and raw materials. Motivate and support their career development and expanding technical expertise
  • Anticipate resource requirements, delegate appropriately, and assure work is prioritized and focused
  • Foster teamwork and drive project/process improvements.

65%

Lead MQ activities in the following areas:

  • Tech transfer (new product introduction)
  • Change management
  • Continuous lifecycle management
  • Ensure appropriate assessment of the following Quality System elements for material qualification:
  • Quality Risk Management program
  • CAPAs
  • Change Controls
  • Deviations
  • GMP Investigations
  • Supplier Notification of Change

Champion site projects involving QC released raw materials and single use materials:  

  • Lead development of technical strategy/philosophy for MQ activities
  • Represent MQ during tech transfer activities as required.
  • Represent MQ during site GMP activities and participate on cross-functional teams
  • Own MQ Quality Systems, as required, and manage project through to closure per timelines
  • Lead/support L&E assessment for clinical and commercial programs
  • Initiate plan for complex raw material evaluationIdentify and deploy opportunities for continuous improvements and adoption of best practices
  • Represent MA Bio Ops MQ in the global MQ community of practice. 

20 %

  • Writing, reviewing and approving of technical assessment and reports, technology transfer packages, regulatory submissions and presentations.

5%

  • Participate in regulatory agency inspections for MQ.
  • Train other Takeda staff on MQ methods and practices.

Education and Experience Requirements

Essential:  PhD (8+ years), MS (10+ years) or BS (12+ years) in Polymer/Chemical /Biochemical Engineering or related discipline with relevant experience in Single-Use Technologies and Raw Material Qualification or related field with a minimum of 6 years relevant experience. 

Desired: Prior experience with single use manufacturing equipment design, raw material selection, specification development and qualification.  Lead departmental initiatives and project teams.  Ideal candidate should be familiar with major suppliers of single use systems, standards for material selection and methods for testing the quality attributes as well as leachable and extractables. 

Key Skills, Abilities, and Competencies

  • A recognized expert in material qualification
  • Demonstrate high-level of professionalism and business etiquette when communicating with cross-functional teams, vendors and external consultants
  • Ability to manage numerous priorities simultaneously and prioritize projects to meet deadlines- strong business acumen
  • Lead problem resolution meetings/teams effectively and provide technically sound inputs and influence others
  • Ability to interact well with others (customers, peers and others in more senior positions) and to supervise the work of FTEs/contractors
  • Strong written and verbal communication skills
  • Proficient in the use of Microsoft Office including Word, Excel, Visio, and Power Point
  • Working knowledge of GMP manufacturing processes and a comprehensive understanding of dependencies between materials, processes, and final product

Complexity and Problem Solving

  • Thorough understanding of biopharmaceutical manufacturing process, material flow, unit operations.
  • Ability to influence others (internal and external). Apply industry guidelines and applicable technology standards to decision making processes
  • Commitment to sound methodologies and best practices.
  • Ability to develop sound business justifications and identify key financial and compliance drivers to support project proposals
  • Effectively communicate issues cross-functionally in a timely manner
  • Poses a comprehensive understanding of industry regulations and cGMP compliance

Internal and External Contacts

  • Consult and collaborate with cross-functional teams including but not limited to Quality Assurance, Quality Control, Supplier Quality, Supply Chain,  Procurement, Manufacturing, Engineering, Operational Excellence & Training.
  • Act as a representative in cross functional teams, leading the implementation of new business solutions for material qualification systems.
  • Interacts effectively and professionally with vendors and consultants and resolving singe use system issues
  • Act as a Takeda representative on external organizations (such as BPOG and BPSA), collaborating with others to form an industry network, sharing best practices and identifying areas of improvement, as applicable.

Other Job Requirements

  • Occasionally, it may be necessary to travel to other Takeda locations to attend business meetings (less than 10% time) and professional trainings or industry conferences.

This job posting excludes CO applicants.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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