Manufacturing Associate III
Location:
Brooklyn Park , Minnesota
Posted:
November 22, 2017
Reference:
1703015

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manufacturing Associate III in our Brooklyn Park, MN office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Associate III working on the Manufacturing team, you will be empowered to support biologic production operations and maintain cGMP compliance, and a typical day will include:

POSITION 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


POSITION 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 areas.
  • Supports/leads deviation investigations and participates in cross functional project teams, supports technical transfers with relevant teams/ individuals.




Qualifications:


EDUCATION, EXPERIENCE, BEHAVIORAL 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.




LICENSES/CERTIFICATIONS:

  • N/A


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


WHAT TAKEDA CAN OFFER YOU:
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs


Empowering Our People to Shine

Learn more at takedajobs.com .



Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-MJ1-USA




A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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