Process Engineer

ALOIS Solutions; North Carolina; On-site; USD 65,000 - 85,000; Full time

Job summary

ALOIS Solutions is seeking a Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support for rAAV vector research and gene therapy programs at our RTP, NC site. You will execute both upstream and downstream bioprocessing activities, document results, and support development and characterization efforts.

Qualifications include a BS or MS in related fields, 2+ years (BS) or 0+ years (MS), familiarity with DOE concepts, and experience in cGMP environments.

Qualifications

• BS or MS in Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or related field.
• 2+ years with BS or 0+ years with MS in lab research or biologics manufacturing.
• Experience or familiarity with upstream and/or downstream bioprocessing.
• Ability to execute experiments under established protocols and meet deliverables.
• On-site work in a fast-paced laboratory environment.
• Experience in cGMP manufacturing or manufacturing-support labs.
• Hands-on experience with scale-up/scale-down or process characterization.
• Familiarity with DOE concepts and experimental execution.
• Experience with JMP or similar statistical tools.
• Strong Word, Excel, and PowerPoint skills.
• Attention to detail and data accuracy.

Responsibilities

• Execute routine rAAV manufacturing and laboratory activities following protocols and batch records.
• Perform upstream and downstream bioprocessing including cell culture, vector production, centrifugation, filtration, and chromatography.
• Support process development, characterization, robustness testing, and small/pilot-scale experiments.
• Accurately document laboratory activities, experimental results, and manufacturing data.
• Assist with batch records, data compilation, data review, troubleshooting, and manufacturing investigations.
• Support equipment setup, operation, maintenance, and daily laboratory activities.
• Maintain a clean, organized, inspection-ready laboratory environment.
• Follow safety, quality, SOP, and data integrity requirements.

Skills

Upstream bioprocessing

Downstream bioprocessing

DOE concepts

JMP software

Documentation accuracy

GxP/cGMP familiarity

Microsoft Office (Word/Excel/PowerPpt)

Education

BS or MS in Biotechnology/Chemistry/Biochemistry/Engineering

Tools

JMP

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Now Hiring: Process Engineer - Pharmaceuticals I

Location: RTP, NC 27709

Duration: 12 Months

We are seeking a Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support for AAV (rAAV) vector research and gene therapy programs.

• Execute routine rAAV manufacturing and laboratory activities following established protocols and batch records.
• Perform upstream and downstream bioprocessing, including cell culture, vector production, centrifugation, filtration, and chromatography.
• Support process development, process characterization, robustness testing, and small/pilot-scale experiments.
• Accurately document laboratory activities, experimental results, and manufacturing data.
• Assist with batch records, data compilation, data review, troubleshooting, and manufacturing investigations.
• Support equipment setup, operation, routine maintenance, and daily laboratory activities.
• Maintain a clean, organized, and inspection-ready laboratory environment.
• Follow all safety, quality, SOP, and data integrity requirements.

Required Qualifications

• BS or MS in Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or a related biological/engineering discipline.
• 2+ years of relevant experience with a BS or 0+ years with an MS in laboratory research or biologics manufacturing.
• Experience or familiarity with upstream and/or downstream bioprocessing.
• Ability to execute experiments under established protocols and meet scheduled deliverables.
• Ability to work on-site in a fast-paced laboratory environment.
• Experience in cGMP manufacturing or manufacturing-support laboratories.
• Hands-on experience with scale-up/scale-down or process characterization.
• Familiarity with DOE concepts and experimental execution.
• Experience with JMP or similar statistical tools.
• Strong Microsoft Word, Excel, and PowerPoint skills.
• Excellent attention to detail, data accuracy, and documentation.