Manufacturing Associate I - Night ShiftApply Now Job ID 1603089 Date posted12/07/2016 LocationBrooklyn Park, Minnesota, United States;
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 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
- May author/ review/improve SOP’s, batch records, protocols and technical reports
- Actively participates in training activities, managing their individual training plan.Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
EDUCATION, BEHAVIOURAL 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.
- On rare occasions, travel may be required to offsite meetings or training event
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