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 I 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 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
- 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.
/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.
- Dispensing, labeling, transfer/staging of raw materials and parts
- Assembly/disassembly, cleaning and sterilization of components, parts
- Maintaining equipment, area and cleaning logbooks
- Cleaning sanitizing production rooms and equipment,
- Stocking production and cleaning supplies
- May author/ review/improve SOP s, batch records, protocols and technical
- Actively participates in training activities, managing their individual
and knowledgeable in the operation and basic troubleshooting of at least one manufacturing
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
Knowledge, competencies and skills:
- Basic 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.
- Familiar with or experience with cGMP Biotech or Pharmaceutical operations:
- cGMP: Understands basic 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 a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
- Possesses a basic understanding of the scientific theory of biologics manufacturing:
understands basic 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 basic equipment understanding, including understanding equipment function and application.
- Proficient in MS Office and related PC skills
- Must have the ability to work either Day or Night shift.
- Bachelor s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience, or Associate s Degree in a scientific or engineering discipline with a minimum of 0-2 years related experience, or High School Diploma with a minimum of 1-2 years relevant experience.
- 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.
- 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
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.