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16 days old

Sr. Tech Transfer Engineer, Manufacturing Quality Sciences, Irvine, CA

Kelly Services
Tustin, CA 92781
**Sr. Tech Transfer Engineer (Downstream), Manufacturing Quality Sciences, Irvine, CA**



**Position Type:** Direct Hire



**Summary/Objective:**




+ The Manufacturing Quality Sciences (MQS) Sr. Engineer (III) will assist in the technical transfer of process from client(s) and/or Process Development to Manufacturing scale. Responsible for continuous process improvement in manufactured products.

+ Where issues or improvements are identified, this role will propose viable solutions including a final product impact assessment. Will identify elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need a complete revision.

+ Review discrepancies assist investigation activities and prepare a CAPA as appropriate. Propose innovative methods/procedures for gap analysis and reduction of deviations.

+ Will prepare written reports and presentations for meetings as assigned.

+ Review 'Engineering Run' Batch Records prior to final QA review and approval.



**Technical Duties/Responsibilities & Essential Functions:** _(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)_




+ Function as SME on the production floor for Downstream operations.

+ Actively assist in the technology transfer from Process Development (PD) to cGMP Manufacturing.

+ Assist in the design and execution of studies to support MFG production.

+ Perform gap analyses on tech transfers.

+ Write technical risk assessments.

+ Identify and implement efficiencies for manufacturing processes.

+ Ability to quickly identify process issues and resolve them expeditiously with minimal impact to product quality.

+ Ability to perform scientifically sound root cause investigations and identify effective CAPAs.

+ Review batch production records for engineering runs.



**Supervision Received:**



General supervision: routine duties are performed with minimal supervision; standard practices or procedures allow analyst to proceed alone at routine work; work is reviewed upon completion.



**Position Type/Expected Hours of Work:**



This role is a full-time, exempt position with flexible scheduling due to operations/scheduling. General days and hours of work are Monday through Friday, unless otherwise stated by Supervisor. The incumbent may be required to work weekends as necessary.



**Education and/or Experience:**




+ A Bachelor's degree in chemical engineering or a related scientific/life science or higher is required.

+ Biopharmaceutical experience is required - the incumbent must possess 2 to 3 years in technical experience in industry or in graduate level studies, or equivalent combination of education and experience.

+ Minimum of 2 - 3 years' experience working with biologics purification.

+ Ability to think creatively to address complex scientific/engineering problems.

+ Ability to understand basic cell culture, bioreactor, chromatography theory, viral filtration, and ultrafiltration and be able to apply it to real-time scenarios.

+ Proficient in personal computer skills, including e-mail, record keeping, routine database activity, GMP analyst, word processing, spreadsheets, and graphics.

+ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

+ Ability to write technical reports and correspondence.

+ Ability to speak effectively before groups of customers or employees of organization.



**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:** https://calendly.com/gracepiper/15min-1




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-09 Expires: 2020-11-09

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Sr. Tech Transfer Engineer, Manufacturing Quality Sciences, Irvine, CA

Kelly Services
Tustin, CA 92781

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