Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manufacturing Associate II in our Brooklyn Park, MN office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Manufacturing Associate II working on the Manufacturing team, you will be empowered to use your cGMP experience to improve process operations. 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.
- 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- 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.
Competencies and Skills:
- 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
- Must have the ability to work either Day or Night shift.
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Brooklyn Park, MN