Commissioning & Qualification Lead, Japan New Plasma Facility Project

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Job Description
About Takeda
”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
OBJECTIVES/PURPOSE
This position is responsible for oversight of the commissioning and qualification (CQ) activities of a new Plasma Manu-facturing facility at a Takeda GMP Manufacturing Site, including but not limited to, commissioning and qualification of equipment, critical systems/utilities, computerized systems, facilities.

• Activities include managing commissioning & qualification personnel (both internal employees and external contractors/vendors) and projects within boundaries of quality, time and budget.
• Reviews and approves Commissioning & Qualification documents and provides general direction to technical staff.
• Interfaces with Engineering, Manufacturing, Regulatory Affairs, Quality Assurance, Quality Operations, Quality Control, Quality Systems, and other departments, as appropriate.
  

Accountabilities

• Manage, identify, hire, and develop a team to support commissioning and qualification of a new Plasma Manufac-turing facility. Manage continued growth, development, and retention of the team.
• Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.
• Responsible for planning, scheduling, and leading commissioning and qualification assignments. Must demon-strate competent and effective planning, coordination, and organizational skills.
• Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification ele-ments, as applicable, to develop the commissioning and qualification strategy based on concepts of risk-based CQ which includes user requirements, functional specifications, design specifications, commissioning and qualifica-tion. Emphasis is on ensuring commissioning and qualification activities meet defined timelines and budget while being in compliance with regulatory guidelines and industry standards.
• Guide peers in Commissioning and Qualification and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results.
• Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate.
• Ability to present a course of action to management and project team using both written and verbal communication tools.
• Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present commissioning and qualification strategy and protocols in regulatory inspections.
• Supervise commissioning and qualification personnel, contractors and outside vendors to meet project timelines, goals and milestones.
• Monitor and report commissioning and qualification costs including capital and cross-functional expenses.
• Perform other duties as directed by supervisor.
  

DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise

• Must have vast experience, proficiency and leadership in pharmaceutical/biotech commissioning and qualification of large capital projects. which includes the writing and executing of protocols and standard operating proce-dures.
• Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all commissioning and qualification elements.
  

Leadership

• Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems.
• Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization.
  

Decision-making and Autonomy

• Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team management.

Interaction

• Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to meet timelines, budgets and desired outcomes.
  

Innovation

• Must be able to lead and implement optimization of processes within the department or the site.
  

Complexity

• Must have advanced experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.
  

Education, Behavioural Competencies And Skills

• Bachelors’ degree in Engineering discipline required. Ideally 7+ years of related experience with 5+ years as a supervisor
• Experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems preferred.
• Experience in managing commissioning and qualification of a large capital project (e.g. new facility installation) is preferred. Experience in Plasma manufacturing is a plus.
• Strong knowledge of risk-based CQ approach (i.e. ISPE Baseline Guide 5 on Commissioning and Qualification) is preferred.
• Prior experience in validation and in the use of KNEAT (paperless validation system) is a plus.
• Prior experience interacting with the FDA and other regulatory agencies preferred.
• Project management experience preferred
  

Additional Information

• Will work mostly in an office environment with requirements to work in manufacturing and support areas.
• Will work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• May work in a hot/cold, wet environment and climb up into large processing tanks.
• Will work in Cleanrooms, including cold/hot storage conditions.
• May work in a loud area that requires hearing protection and other protective equipment to be worn.
• Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks).
• Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.
• Must be able to work multiple shifts, including weekends and extended hours, as required.
• 5% travel may be required to other Takeda facilities in order to manage projects related to these facilities or interact with other commissioning and qualification colleagues and/or as part of professional development.
  

What Takeda Can Offer You
Allowances Commutation, Housing, Overtime Work etc.
Salary Increase Annually
Bonus Payment Twice a year
Working Hours Headquarters (Osaka/ Tokyo) 9 00-17 30, Production Sites (Osaka/Yamaguchi) 8 00-16 45, (Narita) 8 30-17 15, Research Site (Kanagawa) 9 00-17 45
Holidays Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles Flextime, Telework
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Better Health, Brighter Future
Locations
Osaka (Juso), Japan
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time