Manufacturing Technician II
- Employer
- Resilience
- Location
- Durham, NC
- Start date
- May 11, 2023
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Bio NC
Job Details
Manufacturing Associate II Job Description
Position Summary & Role
The Manufacturing Department performs small and large operations, including but not limited to Buffer Preparation, Cell Culture, Purification, MFG Support, and, Drug Product Manufacturing ( Visual Inspection/Labeling) activities in our RTP Facility. This associate will contribute to the buildout and qualification of new manufacturing suites for viral vectors and vaccines, establishing state-of-the-art manufacturing operations. This position is primarily day shift (Sun-Wed), including occasional holidays and weekends but could be adjusted to cover the potential workload.
Job Responsibilities
- Responsible for assisting with startup activities in the area of responsibility.
- Assists in commissioning & qualification of production equipment.
- Assists in the review & creation of operation documents by providing input to technical composition of documents.
- Operates on the manufacturing floor in accordance with cGMP and standard operating procedures.
- Prepares equipment for manufacturing operations and monitors equipment to meet process specifications.
- Uses and maintains bench-top equipment in accordance with relevant procedures.
- Effectively demonstrates an understanding of cGMPs & applies them to specific responsibilities.
- Follows accurate oral & written procedures when operating production equipment & performing processing steps.
- Maintains orderliness of process area.
- Practices safe work habits and adheres to Resilience’s safety procedures and guidelines.
- Assists in training of new staff.
- Utilizes manufacturing knowledge to improve process operations and affect positive change.
- Escalates issues related to product and safety to senior staff.
- Maintain suites/Kanban stocked for production.
Preferred Experience, Education & Qualifications
- High School Diploma/GED and 3+ years in cGMP manufacturing environment or Bachelor’s degree and 3+ years experience
- Ability to lift a minimum of 40 lbs.
- Ability to stand for 6 hours in a production suite
- Ability to problem solve/ troubleshoot and understand resources to accomplish tasks
- Perform equipment set-up, changeover, and clean-up appropriate for a scheduled production run.
- Accurate documentation of production processes on production records using GDP
- Ability to gown and gain entry to manufacturing areas
- Ability to work weekends, including holidays, as scheduled.
- Safety minded.
Other Ideal Personal Characteristics:
- Associate's or Bachelor's Degree - Life Sciences
- Familiarity with Manufacturing Control Systems (i.e. Delta V, D-365, Novatek)
- Experience with Gene Therapy operations.
- Ability to pass an eye exam.
Company
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience
- Website
- http://www.resilience.com/
- Location
-
9310 Athena Circles
La Jolla
CA
92037
United States
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