Brooklyn Park, Minnesota
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
A Global Top Employer
Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Validation EngineerApply Now
Are you looking for a patient-focused,innovation-driven company that will inspireyou and empower you to shine? Join us as a Validation Engineer in our Brooklyn Park office.
- Support one or more validation disciplines (e.g., cleaning, computerizes systems, sterilization) at a multi-product biologics facility using a risk-based approach.
- Participate in multi-disciplinary teams in the implementation of validation activities. Author and execute protocols, final reports, procedures, and other documents as necessary.
- Represent Takeda during regulatory, corporate, division and third-party inspections; defend the validation program(s) to auditors and inspectors; support regulatory submission processes as required.
- Own and/or author controlled, and uncontrolled documentation associated with assigned validation discipline(s); maintain and improve this documentation as necessary to maintain compliance to government regulations, internal corporate requirements, current industry practices, business needs, and current industry best-practices.
- Develop and execute studies, commissioning and validation protocols. Assist in deviation resolution, summarize results, and author final reports. Plan and manage protocol execution, and coordinate with other departments as necessary.
- Support investigation and change control processes when needed.
- Complete mandatory training within required timeframe.
- Perform other duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Preferred Combination of Education and Experience:
- A minimum of a BA or BS in chemical, mechanical, industrial or electrical engineering; alternatively, a combination of military and industry experience and training is acceptable.
- Other degrees, such as a BA or BS in biology, chemistry, math, molecular biology and/or other life science, are acceptable if the candidate has relevant experience (e.g. education or employment in sciences or validation).
- At least two (2) to four (4) years of relevant experience within a Validation, Engineering, Technical Services, and/or Manufacturing role in the pharmaceutical, medical device, biotechnology and/or biopharmaceutical industries.
- With a graduate degree, or relevant training and experience, at least zero (0) to two (2) years of relevant experience within a Validation, Engineering, Technical Services, and/or Manufacturing role is required.
Knowledge, competencies and skills:
- Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Ability to manage and prioritize multiple activities concurrently.
- Proficient in Microsoft Word and Excel, Project and other desktop computing software.
- Experience with protocol development and execution, deviation identification and resolution, and summary/final report authoring. Experience performing statistical analysis of validation test results.
- Familiar with/experience in protein purification from cell culture processes. Understanding of biochemical and microbiological methods supporting the product line.
- Project management experience
- Previous validation experience in Rockwell Automation, FTView SE, ControlLogix, FTBatch, SQL Databases and OSI Pi as well as lab equipment and software such as QC LIMS and Empower, building automation, and IT infrastructure preferred.
- Considered a validation Subject Matter Expert (SME) in one or more areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
- Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP® 5 requirements desirable.
- Experience with moist-heat sanitization/sterilization cycle qualification and understanding of current regulatory and industry guidelines.
- Demonstrated ability to comprehend mechanical/electrical drawings and related engineering prints for CQV activities.
- In general, the position requires a combination of sedentary work and walking around the cGMP manufacturing facility.
- May occasionally work in a clean room environment and wear special garments and personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
- May be required to travel - less than 15%
Brooklyn Park, MN
Job ID R0021855