Validation Specialist-1st shift
Portsmouth, New Hampshire | Contract
This company is one of the world' s leading suppliers to the Pharma & Biotech industries!
They are now looking for a Validation Specialist!
Key Accountabilities and Duties:
Perform Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.
Perform change control assessments and assign associated validation activities to ensure compliance with regulatory requirements.
Demonstrate a thorough understanding of biopharmaceutical equipment, cleaning processes and validation procedures for Operational Qualification (OQ) and Performance
Qualification (PQ). Develop validation protocols from Validation plans and engineering documents.
Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations
Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
Able to represent Equipment and Cleaning Validation as a System Matter Expert (SME).
Trainer on Equipment and Cleaning Validation philosophy, approach and procedures.
Perform other duties as assigned.
Minimum Required Qualifications/Skills:
Bachelor’ s degree in Science or technical discipline Minimum 4 years of industry experience SME level of understanding of biopharmaceutical manufacturing equipment and the role of validation.
Strong technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
Strong written and oral communication skills and ability to work interdepartmentally without supervision in an effective manner to carry out daily duties.
Strong organizational and time management skills
Exercises judgment within defined procedures and practices to determine appropriate action.
Seeks guidance from senior team members and management as necessary.