- Attend/run daily morning meetings
- 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
- Demonstrating general knowledge of aseptic techniques
- Perform troubleshooting activities according to SOPs
- Execute routine and non-routine production operations according to MFG schedule
- Informing management of events impacting schedule
- 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
- Communicate cross-functionally for sample submission and process monitoring as required per BPR/SLR
- Carry out work in a safe manner, notifying management of safety issues and risks
- Provide Process & Equipment Training as a Qualified Trainer
- Maintain up-to-date training folder for applicable processes
- May be required to work at least four holidays in the calendar year
- Act as subject matter expert for improvement projects
- Perform scheduled cleaning of equipment
- Assembly and disassembly of process equipment
- Perform standardization of equipment
- Perform 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
- Request new logbooks as needed
- Propose document revisions and support improvements as needed
- Escalate process improvement ideas and support as necessary
- Develop and maintain personal development plan
- Provide annual performance self-assessment
- Normally requires a high school diploma and 4-6 years related cGMP industry experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of cGMP Manufacturing experience or Bachelor's degree in life Sciences/Engineering field with 1-3 years of cGMP experience
- Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
- Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures
- Hands-on experience in writing and reviewing documentation
- Experience in (bio)-manufacturing unit operations (USP and/or DSP)
- Good writing and oral communication skills
- Applies experience and skills to complete assigned work within own area of expertise
- Works within standard operating procedures and/or scientific methods
- Comfortably able to lift up to 40lbs
- Has process-oriented way of thinking and working
- Is detail oriented
- Is self-organized
- Is able to communicate in professional way on diverse levels and channels
- Is capable of taking initiative when necessary
- Has a flexible attitude in a challenging environment
- Is intrinsically motivated Our benefits
- Medical, Dental, and Vision plans with the majority of premiums paid by the company
- Stock Options and Bonus programs
- 401(k) Retirement Savings Plan with company match
- Generous paid time off with up to four weeks of vacation, plus holidays
- 100% company-paid life insurance and short-term and long-term disability
- Dependent Care and Health Flexible Spending Accounts
- Tuition Reimbursement
- Fitness Membership Reimbursement
-
SCA II
3 weeks ago
Watermark Risk Management International, LLC Massachusetts, United StatesCome make your mark with Watermark · FOUNDED BY USAF VETERANS in 2007, we are proud to be a Service-Disabled Veteran Owned Small Business. · SUBJECT MATTER EXPERTS specializing in security and risk management. We're intimately familiar with DOD security programs and mission requi ...
Manufacturing Technician III - Massachusetts, United States - uniQure
3 weeks ago
Description
Place in the Organization
Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, QC, QA, Engineering and Validation.
With limited supervision this 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. Will support engineering and validation activities.
Key result areas (major duties, accountabilities and responsibilities)
Independently perform manufacturing of uniQure's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements.
This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following:
This individual will manage equipment and support facility related projects by:
Working with supervision this individual will:
Qualifications
Core competencies
At uniQure, we offer competitive benefits packages that are designed to attract and retain bright, talented people. While they vary by location, below are a few of the benefits offered as part of our comprehensive package for our U.S. employees:
