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Validation Engineer

Sunrise Systems Inc

Devens, MA

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JOB DETAILS
SKILLS
Asset Management, Biology, Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Computer Systems, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Disaster Recovery, Document Control, Equipment Validation, GMP (Good Manufacturing Practices), Identify Issues, Preventative Maintenance, Problem Solving Skills, Purchasing/Procurement, Quality Control, Quality Management, Regulations, Regulatory Requirements, Requirements Management, Risk Analysis, Root Cause Analysis, Scripting (Scripting Languages), Software Debugging, Software Testing, Standard Operating Procedures (SOP), System Validation, Team Player, Test Scripts, Validation Plan, Writing Skills
LOCATION
Devens, MA
POSTED
12 days ago
Job Title: Validation Engineer
Job ID:26-02997
Job Location: Devens, MA, 01434
Duration: 06 Months 

Description:
  • Work Schedule: Mon-Fri(normal business hours) 100% onsite with some flexibility
Responsibilities will include (but not limited to):
  • Manage the entire lifecycle of QC laboratory instruments from procurement to qualification to decommissioning, ensuring all activities are in compliance with applicable policies/regulations.
  • Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, and qualification summary reports
  • Author/execute computer system validation scripts using an electronic validation database (ALM), or paper-based
  • Own change controls specific to the qualification of QC instruments and their associated software
  • Update the asset management database to reflect new assets, calibrations, and preventative maintenances
  • Author instrument operational SOPs as needed
  • Coordinate/interface/host vendors on site
  • Champions qualification deviations/software defects, identifying root causes, and Corrective Actions/Preventive Actions (CA/Client)
  • Acts as the liaison between Digital Plant (IT) and lab departments
  • Execute periodic assessments/decommissioning, as needed
Qualifications and Experience Required:
  • Required Bachelor's degree or Master's degree in Engineering, Chemistry, Biology, or in a related, scientific/computer-based field.
  • Minimum of 2 – 4+ years' experience in the biopharmaceutical industry or equivalent combination of education and validation/lab experience will be considered.
  • Quality management system experience including: document control/management, change controls, investigations, deviations, electronic validation databases, asset management database
  • Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery
  •  Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
  • Demonstrated success in cross-functional influencing, strong communication, and collaboration skills
  • Must have GMP experience
  • Microsoft Office Applications, preferred.
  • Computer system validation experience, preferred
  • Equipment validation experience is a plus
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com

About the Company

S

Sunrise Systems Inc

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.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/