Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Manufacturing Technician - II
Location: Oceanside, CA
Duration: 9 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Manufacturing Technician - II
Location: Oceanside, CA
Duration: 9 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
- Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
- Ensure right-the-first-time performance of all process steps specific to the step of operation, as well as help drive the safety-first culture at Kite Oceanside.
- Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
- Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
- Under supervision, perform Chromatography and Ultrafiltration/Diafiltration operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper cleanroom etiquette, Good Documentation Practices (GDP), and sound scientific methods.
- Prepare and use single use systems to support buffer preparation and filter integrity testing.
- Assist with manual and/or automated fill of harvested viral vector material.
- Escalate processing and equipment issues as needed.
- Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
- Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
- Ability to work effectively in an inclusive, cross-functional, team-based environment.
- Able to work off shift hours and weekend.
- Additional duties as assigned.
Basic Qualifications:
- Bachelor s Degree Or
- AA Degree with 2+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry Or
- High School diploma with 3+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry
- Preferred Qualifications:
- 0+ years of experience with Bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education
- Prior experience with biopharmaceutical, cell or gene therapy manufacturing is a plus
- Knowledge of the Current Good Manufacturing Practices (cGMP's) desired
- Excellent skills in Microsoft Word, Excel and data analysis
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills
- Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment
- Ability to lift 40 lbs repeatedly and stand for hours at time
- Able to work off shift hours and weekend
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Oceanside, CA |
| Industry | Computer/IT Services |
| Salary | $24–$28 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Asepsisunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Business Solutionsunmatched
- Chromatographyunmatched
- Cleanroomunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Data Analysisunmatched
- Diversityunmatched
- Document Managementunmatched
- Documentationunmatched
- Drug Developmentunmatched
- Facilities Engineeringunmatched
- GMP (Good Manufacturing Practices)unmatched
- Gene Therapyunmatched
- HIV/AIDS (Acquired Immune Deficiency Syndrome)unmatched
- Hepatitis Bunmatched
- Hepatitis Cunmatched
- High School Diplomaunmatched
- Interpersonal Skillsunmatched
- Inventory Transactionsunmatched
- Lift/Move 40 Poundsunmatched
- Manufacturingunmatched
- Manufacturing Execution Systems (MES)unmatched
- Manufacturing Operationsunmatched
- Manufacturing Requirementsunmatched
- Manufacturing/Industrial Processesunmatched
- Microsoft Excelunmatched
- Microsoft Wordunmatched
- Presentation/Verbal Skillsunmatched
- Quality Engineeringunmatched
- Research & Development (R&D)unmatched
- Standard Operating Procedures (SOP)unmatched
- Team Playerunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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