Highlights
Job Responsibilities: Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (Client/APV), and other Lifecycle Management changes. The Senior Specialist participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.
Numbers & Facts
| Location | MA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: Assistant Process Engineer
ID: 26-05321
Location: Devens, MA 01434 (50% onsite required)
Work Schedule: Mon-Fri (normal business hours)
Must haves:
- Bachelor's degree required
- Experience in Technical writing such as SOPs, protocols, summary reports and/or change controls.
- Manufacturing background with Manufacturing Science and Technology Validation experience
Summary
- The Senior Specialist, MS&T Validation provides process validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.
Job Responsibilities:
- Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (Client/APV), and other Lifecycle Management changes.
- Prepares written protocols/reports/summaries supporting validation studies.
- Ensures safe and compliant cGMP operations, maintains permanent inspection readiness.
- This position reports to the Associate Director of Manufacturing Science and Technology Validation.
Specific Knowledge, Skills, Abilities:
- Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations
- Excellent verbal/written communication skills
Education/Experience/ Licenses/Certifications
- Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, is required
- A minimum of 2 years' experience in biopharmaceutical operations, or its equivalent is required.
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
Similar Job Searches
Systems Engineer Jobs in Devens, MADesign Engineer Jobs in Devens, MAPlanning Engineer Jobs in Devens, MAField Service Manager Jobs in Devens, MAControls Engineer Jobs in Devens, MAEngineering Manager Jobs in Devens, MAProcess Engineer Jobs in Boxborough, MAProcess Engineer Jobs in Chelmsford, MAProcess Engineer Jobs in Nashua, NHProcess Engineer Jobs in Cambridge, MA