Manufacturing Associate IIIApply Now Job ID 1602838 Date posted11/15/2016 LocationBrooklyn Park, Minnesota, United States;
- The Manufacturing Associate III 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 is responsible for training less experienced or new manufacturing associates.
- He or she is responsible for supporting/leading deviation investigations and participates in cross functional projects teams, support technical transfers with relevant teams/individuals and is involved in other assignments as directed.
- He or she may act as team lead in absence of a supervisor
- 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 moderate to complex mechanical operations.
- Proficient and knowledgeable in the operation and moderate to complex troubleshooting of two or more manufacturing area’s.
- Supports/leads deviation investigations and participates in cross functional project teams, supports 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).
- Possess excellent written and oral communication skills.
- 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
- Actively pursues learning of required skills, new skills, and new equipment
- 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.
- 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 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.
- On rare occasions, travel may be required to offsite meetings or training event
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