22 days old

Biopharmaceutical Process Engineer

Kelly Services
Indianapolis, IN 46202
Kelly Science & Clinical has a new, permanent opportunity for a Biopharmaceutical Process Engineer with a Biotech startup company in Cleveland, OH. Relocation assistance provided!

Day-to-Day Responsibilities:

+ Reports to Director of Manufacturing Science & Tech

+ Lead the design and launch of the Next Generation Manufacturing process

+ Lead process FMEAs to understand process and product risks

+ Evaluate, develop, and qualify new technology, equipment, and raw materials for cell therapy manufacturing

+ Collaborate with cross-functional team members in Quality, Supply Chain, Facilities, and Process Development spaces to ensure successful launch

+ Assure process reliability and robustness

+ Evaluate process automation for GMP manufacturing

+ Ensure collaboration with internal and external stakeholders/vendors/CMOs to support materials changes and define requirements/specifications

+ Support investigations, identify root causes, and determine CAPAs

+ Author, review, and approve technical documentation such as, but not limited to: batch records, SOPs, IQ/OQ/PQ testing, process validation

You are an excellent fit if you meet the following qualifications:

+ BS degree in Biomedical Engineering or Life Sciences discipline

+ Must have 3+ years of Industry experience in (bio)pharmaceutical manufacturing, tech transfer, and process development

+ Bioreactor experience, given preference

+ Demonstrated experience with process optimization, CAPAs, and root cause analysis

+ Demonstrated knowledge of pharmaceutical manufacturing, aseptic processing, and cell therapy products

+ Demonstrated ability to think critically, troubleshoot, and implement process improvements

+ Above average communication skills, both verbal and written

+ Thrives in a fast-paced, dynamic startup environment

+ Must be comfortable working in both an office space and aseptic manufacturing floor

+ Able to travel domestically and internationally, up to 10%

+ Authorized to work in the US

This position will work Monday Friday 1 st shift, but may require nights and weekends. Position will start as remote-based. Salary will range between $80k-$110k, based on relevant years of experience. If you, or someone you know, would be interested in this opportunity please apply online today!

**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-09-06 Expires: 2021-10-07

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Biopharmaceutical Process Engineer

Kelly Services
Indianapolis, IN 46202

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