Manufacturing Technician I/II/III (2nd Shift)
Confirmed live in the last 24 hours
Genezen
Job Description
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.
With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products.
This position is located in Lexington, MA and reports to the MFG Supervisor.
ESSENTIAL JOB FUNCTIONS
This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.
Primary responsibilities include the following:
- Attend daily meetings including shift hand off and ensure relevant information is shared between shifts.
- Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state
- Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
- Demonstrating general knowledge of aseptic techniques
- Perform troubleshooting activities according to SOPs
- Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed.
- Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms
- Perform page reviews in BPRs, SLRs, Logbooks, and Forms
- Carry out work in a safe manner, notifying management of safety issues and risks
- Maintain up-to-date training folder for applicable processes
- Required to work holidays and overtime as needed to support the manufacturing process
This individual will manage equipment and support facility related projects by:
- Perform scheduled cleaning of equipment
- Perform standardization of equipment
- Support product change over activities
- Support equipment and process qualifications if needed
- Escalate work requests to Senior or Lead Technicians for submission in work request management system
Staff Technical Training and Development:
- Propose continuous improvement, process, and human performance document revisions
- Escalate and contributes to process improvement and manufacturing Continuous Improvement items.
- Develop and maintain personal development plan
- Provide annual performance self-assessment
SPECIAL JOB REQUIREMENTS
- Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sci
Similar Jobs
Applied Materials
Manufacturing Quality Engineer E2
Boeing
Associate Manufacturing Engineer (Assembly and Installation)
GE HealthCare
Intern Advanced Manufacturing Engineering
Amazon Kuiper Manufacturing Enterprises LLC