Manufacturing Associate III
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 III in our Brooklyn Park, Minnesota office.
Takeda is a global, innovation-driven pharmaceutical leader with 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put patients first for more than 230 years while we live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Associate III working on the Biologics Manufacturing team, you will be empowered to use your GMP experience to improve process operations and develop a thorough understanding of biologics manufacturing, 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/leading deviation investigations and participating in cross functional project teams, supporting technical transfers with relevant teams/individuals.
Acting as team lead in absence of a supervisor
Perform Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system.
Document/Record cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records, SLRs, and equipment logbooks.
Complete/review validation protocols, deviation reports, change controls in accordance with cGMP s
Perform weighing, dispensing of raw materials for media and buffers
Perform preparation of small and large volume media and buffer solutions, filtration and transfer of product
Operate bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
Dispense, label, transfer/stage raw materials and parts
Assemble/disassemble, clean and sterilize of components, parts and equipment
Maintain equipment, area and cleaning logbooks
Clean sanitizing production rooms and equipment
Author/ review/improve SOP s, batch records, protocols and technical reports
Actively participate in training activities, managing their individual training plan.
Utilize Manufacturing knowledge to train others, improve process operations and effect positive change and demonstrate ability to troubleshoot moderate to complex mechanical operations.
Support/lead deviation investigations and participate in cross functional project teams, support technical transfers with relevant teams/ individuals.
EDUCATION, BEHAVIOURAL 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).
- 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
- 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.
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.
- 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
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Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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