Manufacturing Associate II


Are you looking for a patient-focused, innovation-driven 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 II in our Brooklyn Park, Minnesota office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Associate II working on the Biologics Manufacturing team, you will be empowered to use your GMP experience to improve process operations, and a typical day will include:
  • Performing and documenting 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.
  • Training less experienced manufacturing associates.
  • Supporting deviation investigations and may participates in cross functional projects teams, may support technical transfers with relevant teams/individuals and is involved in other assignments as directed.


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 basic mechanical operations.
  • Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing areas.



Qualifications:


REQUIRED QUALIFICATIONS:

  • Advanced 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.
  • Experience with 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 advanced knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
  • Possesses advanced understanding of the scientific theory of biologics manufacturing:
  • understands 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.
  • Possesses advanced equipment understanding, including understanding equipment function and application.
  • Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing area
  • Ability to train less experienced or new manufacturing associates.
  • Proficient in MS Office and related PC skills




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 1-2 years relevant experience, or Associate’s Degree in a scientific or engineering discipline with a minimum of 2-4 years related experience, or High School Diploma with a minimum of 2-6 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.


WHAT TAKEDA CAN OFFER YOU:




To further support and inspire our employees, our benefits include:
  • Company-paid volunteer days
  • Company match of charitable contributions
  • 401(k) with company match, and annual retirement contribution plan
  • Adoption assistance and tuition reimbursement program





Empowering Our People to Shine

www.takedajobs.com



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



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