56505 - SWAT Team Purification Technical Services Representative
- This is an exciting and challenging opportunity to join one of the
Worlds leaders in Biotechnology at the start of a period of
significant expansion in their protein manufacturing business!
- In this position as Technical Services Representative you will be
part of a small troubleshooting -SWAT- team which will be dedicated to
resolving critical protein purification process issues at two
manufacturing sites: an exisiting third party manufacturer in the New
England area and during start-up of a new facility in Indianapolis.
- This position will require a strongly motivated, independent
individual who is flexible with regard to location and has a desire to
be -where the action is- resolving technical issues.
- Working with a diverse group of people from manufacturing and
various support groups you will use sound scientific and statistical
methods to continuously improve the process through variability
- This is an excellent opportunity to become an expert at the
forefront of new technology and to help produce a therapeutic protein
that will save the lives of thousands of people.
NATURE OF THE WORK
- Increase yields by variability reduction and decrease factory loss
due to special cause events or excursions outside the ticket
- Develop and implement new "tools" or methods to streamline
investigations and quickly evaluate possible solutions to reduce
Variation Reduction and Process Investigation
- Definition and characterization of root causes for special cause
- Assist or supervise writing/responding to alerts/deviations.
- Assist in real-time data tracking/evaluation of changes implemented
in response to special cause events.
- Definition and characterization of common cause variation and
minimize reoccurrence of excursions.
Maintenance of RegulatoryDocumentation/Compliance
- Ensure regulatory and cGMP compliance for the process.
- Review and maintain manufacturing tickets to be compliant with
manufacturing, process and regulatory requirements as changes are
- Supply accurate timely updates of the current manufacturing process
problems or excursion. - Maintain processes in a validated state.
- Complete necessary process
qualification/requalification by staying current with regulatory
- Ensure cleaning/sterilization procedures are validated as required
when changes or excursions occur.
The Technical Service Representative should be flexible, sensitive to
the needs of subordinates, peers, management and third party
He/she should be able to work independently and be able to
reprioritize activities quickly. He/she should exhibit leadership
abilities and interact well with others. The Representative should be
technically inquisitive, attentive to detail and must exhibit
excellent problem solving skills.
A minimum of a bachelor's degree in biochemistry, chemistry,
engineering or other related field is required.
A minimum of two years biotech experience is required.
Proficiency in software programs such as JMP or excel for statistical
data analysis and process control charting is preferred.
Primarily located in Indianapolis, but with potential for extended
periods of time in the New England area supporting third party
Please reference job number EL56505 when emailing your resume to
cbarrus at volt.com. We look forward to assisting you in your job
You can view all our open positions at http://www.volt.com
Volt is an Equal Opportunity Employer.