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Intern (VHP Study Co-op)

Kelly Services


Location:
West Chester, PA
Date:
04/18/2018
2018-04-182018-05-17
Job Code:
US24R4LR_BH1437204
Categories:
  • Engineering
Kelly Services
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Job Details

Job Title Intern (VHP Study Co-op)

Jobid US24R4LR_BH1437204

Location: West Chester, PA, 19381, USA

Description **_Intern (VHP Study) - West Chester, PA_**

Kelly Services is currently seeking an **_Intern (VHP Study)_** for one of our top clients in West Chester, PA.

**Projected Duration** : 06/04/2018 to 07/27/2018

**Type** : INTERNSHIP

**Pay Rate:** $15/HR

**Project Description:** The co-op will, under the guidance of DPO, develop a study plan to investigate various parameters related to residual vaporized hydrogen peroxide (VHP) concentration. The timeframe of the co-op assignment corresponds to the start of engineering runs and media fills for the complete isolator line. It will be possible to integrate residual VHP studies into these critical path activities without impacting the project schedule. The co-op will first become familiar with the residual VHP instrument, its operation, and the data generated. Once familiar with the equipment and data collection infrastructure, the co-op will develop and execute the study plan.

**Responsibilities:**


+ An evaluation of VHP sample location on the isolator. There are multiple ports to which the analyzer can be attached, corresponding to different isolator sections. There is currently no data to justify that one sample location is representative of the entire isolator, nor any risk assessment data available to compare results obtained using different access ports.
+ A time/process study to better understand exposure time of primary packaging components and open drug product in each isolator section depending on the process activities that occur in that section. Also include in this evaluation the probability of routine and/or mal-events that would require a line stoppage and manual intervention by operators as this could significantly extend exposure times.
+ A risk assessment of process activities that occur in each isolator section as they relate to possible liberation of absorbed hydrogen peroxide. This must include an evaluation of absorbed hydrogen peroxide on the isolator gloves as these are expected to be the most significant source of outgassing once the aeration cycle is complete. Evaluation should address static (glove not used) and dynamic (gloves in use) conditions.
+ The risk assessment should also address configuration and operational differences when running syringes/solution vials vs lyophilized vial presentations; this may result in different recommendations for residual VHP monitoring depending on line configuration.
+ A comparison of data taken with varying parameters to understand residual VHP behavior across the full isolator interior. Can ports be used interchangeably or does residual concentration vary significantly across the isolator? If variable, provide a scientific rationale for the differences (to demonstrate that we understand what is happening) and justification for sample port used in routine operations.
+ An evaluation of using a validated aeration cycle time (only) vs continuous VHP residual monitoring during filling operations. Risks/benefits for both approaches and rationale for strategy selected.
**Minimum Requirements:**


+ The candidate must be enrolled in an undergraduate or graduate program in Pharmaceutical Sciences, Chemical engineering, Biomedical engineering, Biochemistry, Biotechnology or related field.
+ Individual should be familiar with basic laboratory skills (eg. buffer preparations, lab safety, etc) and have working knowledge or experience with protein or other macromolecules (coursework is acceptable).
+ The candidate will also need to have an ability to work independently and multi-task with strong computer skills in Microsoft Office (Word, Excel and PowerPoint) and demonstrate potential for technical proficiency, scientific creativity, and collaboration with others.
+ Excellent time-management and communication skills are a must.
**Deliverables**


+ Technical Report
+ Oral Presentation given to DPDO
+ New or revised SOP(s) related to residual VHP monitoring, use of the analyzer, and management of the associated data
**If you are interested in the position, please apply to this posting with an updated resume. Qualified candidates will be contacted. Thank you for your time and I look forward to working with you.**

**Lauren Rogers, Kelly Services Scientific Recruiter**

Relevance to Current or Future Work in DPDO: The isolator line being installed in the BMF to support clinical DP filling uses vaporized hydrogen peroxide (VHP) decontamination technology to prepare the isolator for manufacturing. This technology ensures that all critical surfaces inside the isolator are free of viable microorganisms prior to the start of filling operations and is a critical component of the overall sterility assurance strategy. While VHP is quite effective as a surface decontamination method, complete aeration of the gas prior to the introduction of primary packaging components and drug product is essential as biologic products are extremely sensitive to very low levels of residual VHP. The system being installed in the BMF includes a residual VHP analyzer that can detect levels of VHP down to approximately 10 ppb; however, the behavior of very low levels of VHP during/after the aeration cycle inside the isolator is not well understood. Parameters such as sample location, outgassing of absorbed hydrogen peroxide from porous surfaces after aeration is complete, and residual concentration variation over the complete manufacturing cycle should be characterized in order for Teva to fully understand post-aeration conditions inside the isolator. This is essential so that Teva can demonstrate a scientific understanding of the residual VHP phenomena and the potential impact of residual VHP on product quality.

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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