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Manufacturing Associate III

Job ID 1602838 Date posted11/15/2016 LocationBrooklyn Park, Minnesota, United States;
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

  • The Manufacturing Associate III performs and documents cGMP activities to support upstream and downstream production areas and operations . This  involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
  • He or she is responsible for training less experienced or new manufacturing associates.
  • He or she is responsible for supporting/leading deviation investigations and participates in cross functional projects teams, support technical transfers  with relevant teams/individuals and is involved in other assignments as directed.
  • He or she may act as team lead in absence of a supervisor

ACCOUNTABILITIES:

  • Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system.
  • Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records, SLRs, and equipment logbooks.
  • Completes /reviews validation protocols, deviation reports, change controls  in accordance with cGMP’s
  • Performs the weighing, dispensing of raw materials for media and buffers
  • Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product
  • Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders , filter integrity testers etc.
  • Dispensing, labeling, transfer/staging of raw materials and parts
  • Assembly/disassembly, cleaning and sterilization of components, parts and equipment
  • Maintaining equipment, area and cleaning logbooks
  • Cleaning sanitizing production rooms and equipment,
  • Stocking production and cleaning supplies
  • Author/ review/improve SOP’s, batch records, protocols and technical reports
  • Actively participates in training activities, managing their individual training plan.
  • Utilizes Manufacturing knowledge to train others,  improve process operations and affect positive change and demonstrates ability to troubleshoot moderate to complex mechanical operations.
  • Proficient and knowledgeable in the operation and moderate to complex troubleshooting of two or more manufacturing area’s.
  • Supports/leads deviation investigations and participates in cross functional project teams, supports technical transfers with relevant teams/ individuals.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Knowledge, competencies and skills:
  • Good knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures  within the company. General understanding of most areas in Manufacturing and supporting functional groups.
  • Has a good understanding of cGMP Biotech or Pharmaceutical operations
  • cGMP: Understands cGMP requirements and follows those requirements, including requirements for good documentation practices.
  • Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
  • Possess excellent written and oral communication skills.
  • Possesses good knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
  • Possesses a thorough understanding of the scientific theory of biologics manufacturing:
  • Has a good understanding of biotechnology processing - purpose of major unit operations and microbial control concepts
  • Actively pursues learning of required skills, new skills, and new equipment
  • Understand routine procedures upon which they have been trained, is able to revise and create new procedures.
  • Possesses good equipment understanding, including understanding equipment function and application.
  • Proficient and knowledgeable in the operation and moderate to complex troubleshooting of two or more manufacturing area’s
  • Ability to train less experienced or new manufacturing associates.
  • Supports deviation investigations. Participates in cross functional projects teams, supports technical transfers with relevant teams/individuals.
  • Proficient in MS Office and related PC skills.
  • Must have the ability to work either Day or Night shift.
Education:
  • Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 2-4 years relevant experience, or Associate’s Degree in a scientific or engineering discipline with a minimum of 4-6 years related experience, or High School Diploma with a minimum of 4-8 years relevant experience.

PHYSICAL DEMANDS:

  • Is required to stand, operate manufacturing equipment, computer equipment; and is required to wear personal protective equipment (PPE) such as safety shoes, safety glasses and/or hearing protection.
  • May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
  • May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus).
  • May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
  • May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
  • May be required to drive rarely to attend offsite meetings and/or training.
  • May be required to use hearing occasionally when listening for production and equipment alarms.
  • Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
  • May be required to perform visual inspection of production equipment, materials, and activities.
  • May be required to perform occasional overhead reaching during handling of production materials/files/supplies
TRAVEL REQUIREMENTS:
  • On rare occasions, travel may be required to offsite meetings or training event


we are driven to improve people's lives

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Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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Schedule
Full-time