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.
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
Qualifications: REQUIRED QUALIFICATIONS:
- 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.
- 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
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 No Phone Calls or Recruiters Please.