Equipment Validation Specialist IV (263434)
Job Description
Job Description
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title: Equipment Validation Specialist IV
Location: Portsmouth, NH (03801)
Duration: 12 months contract
Pay rate: $50/hr on W2 AI
Job Description:
- Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The role provide Operations, Quality Assurance and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment.
- 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), 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 Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA)
- Perform other duties as assigned
- 4 year degree strongly preferred
- 4 year's experience in Mfg
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.