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 II 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 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:
- The Manufacturing Associate II 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 may be responsible for training less experienced or new manufacturing associates.
- He or she may be responsible for 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.
Processing Steps and/or Manufacturing Support activities, monitoring process
against the batch record, SLR and control system.
cGMP data and information for processing steps and/or equipment activities,
following standard operating procedures. Key documentation includes batch
records, SLRs, and equipment logbooks.
/reviews validation protocols, deviation reports, change controls in accordance with cGMP s
the weighing, dispensing of raw materials for media and buffers
the preparation of small and large volume media and buffer solutions,
filtration and transfer of product
bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders,
filter integrity testers etc.
labeling, transfer/staging of raw materials and parts
cleaning and sterilization of components, parts and equipment
equipment, area and cleaning logbooks
sanitizing production rooms and equipment,
production and cleaning supplies
review/improve SOP s, batch records, protocols and technical reports
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.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
competencies and skills:
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.
with cGMP Biotech or Pharmaceutical operations
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).
excellent written and oral communication skills.
advanced knowledge of non-manufacturing functions such as QC, Regulatory, QA,
and/or Materials Management.
advanced understanding of the scientific theory of biologics manufacturing:
biotechnology processing - purpose of major unit operations and microbial control
pursues learning of required skills, new skills, and new equipment
routine procedures upon which they have been trained.
advanced equipment understanding, including understanding equipment function
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.
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 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
- 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
- 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.
- On rare occasions, travel may be required to offsite meetings or
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.