What are the responsibilities and job description for the Equipment Validation Specialist III position at TalentBurst?
Job Title : Equipment Validation Specialist III
Location : Portsmouth, NH
Duration : 10 months
Job Description : Summary
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.
Key Accountabilities :
- 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.
Qualifications
High School Diploma or Equivalent; (4 year degree strongly preferred) - Science related discipline or relevant experience in the field
Bachelor of Science preferred
Work Experience
dvanced - 5-10 years
Responsibilities
Quality : Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.
Safety : Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety, the safety of their team and the safety of others.
Skills :
Travel : TB_EN
