- Performs daily activities required of vessel production
- Partners with other Bioprocessing Team Members during launches
- Recognizes and solves typical problems that occur in own work area without supervisory approval
- Supports projects of moderate scope (e.g. operational excellence, safety)
- Supports the collection and tracking of area metrics and process control data
- Performs cleaning and preparation of production equipment, and cleaning/disinfecting of production rooms
- Supports the assembly, set-up, and disassembly of production equipment
- Ensures process steps are executed according to defined SOPs and BPRs
- Ensures proper documentation of activities in accordance with cGMPs
- Adheres to the proper handling of chemically hazardous goods
- Interfaces with process automation and electronic business systems
- Supports the revisions of SOPs and BPRs
- Supports qualifications and validation activities, as assigned
- In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope
- Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation
- Trains other team members on minor tasks and equipment
- Other duties, as assigned
- Works within clearly defined standard operating procedures (SOPs) and/or scientific methods
- Uses analytical skills and application of scientific methods or operational processes to perform a variety of activities
- Attempts to solve problems before seeking support of management
- Has ability to differentiate between important and less important tasks within own work and act accordingly
- High School Diploma or GED, required. Associate or Bachelor's degree, preferred.
- 2+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required
- Basic knowledge of cGMP requirements, required
- Experience executing SOPs and documenting work, required
- Basic mechanical aptitude or knowledge of electrical / mechanical equipment, preferred
- Previous cell culture experience, highly preferred
- Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
- Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
- Position may require working holidays, weekends and over-time
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
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3D Bioprocessing Associate II - Durham, United States - HUMACYTE GLOBAL INC
Description
Job Description
Job DescriptionPosition Overview:
The Bioprocessing Associate 2 participates in the hands-on production of Humacyte's regenerative vessels.
Major Accountabilities:
Performs basic/moderate scope processes and serves as a hands-on resource in Manufacturing Humacyte's regenerative vessels by:
Specific Skills:
Education and/or Experience:
Highlighted Perks & Benefits:
**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**
