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QA Validation Specialist 3

Sunrise Systems Inc

Portsmouth, NH

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JOB DETAILS
SKILLS
Analysis Skills, Autoclave, CIP (Clean-in-Place), Change Control, Cleaning Equipment, Corrective and Preventative Action (CAPA) Systems, Document Management, Equipment Maintenance/Repair, Equipment Validation, GMP (Good Manufacturing Practices), Manufacturing, Manufacturing Equipment, Manufacturing Equipment Maintenance, Process Improvement, Quality Assurance, Quality Control, SIP (Session Initiation Protocol), SIP (Sterilization-in-Place), Standard Operating Procedures (SOP), Technical Support, Temperature Mapping, Testing, Validation Plan
LOCATION
Portsmouth, NH
POSTED
1 day ago

Job Title: Equipment Validation Analyst
Job ID: 26-03440
Location: Portsmouth, NH
Duration: 6 Months

Manager's insight:

  • Role is Equipment Validation and Cleaning Validation
  • Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
  • Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is single-use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly drafting SOPs
  • Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient). Looking for a worker to Build Equipment Requalifications in Kneat.

Job Description:

  • Provide Subject Matter Expert support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.
  • Drive/own the validation plans and execution of equipment changes and process improvements.
  • Execution of Installation Qualifications/Operational Qualifications and drafting of Performance Qualifications as required.
  • Perform Equipment Validation activities to include Validation Maintenance Quality Systems review, and requalification to ensure GMP equipment is continuously maintained in a validated state.
  • Program, organize, and maintain Validation equipment and supplies, including dataloggers and probes.
  • Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping, Controlled Storage Rooms and Equipment.
  • Develop validation protocols from plans and engineering documents.
  • Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
  • Perform assigned Quality Systems activities within the Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA)
  • Perform other duties as assigned.

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/

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