System Validation Engineer

Job Title: Equipment Validation Specialist

Location: Portsmouth, NH 03801

Duration: 9 months (possibility for extension)

Position Type: Hourly contract Position (W2 only)

Job 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.

Education

• High School Diploma or Equivalent; (4 year degree strongly preferred) Field of Study Science related discipline or relevant experience in the field
• Bachelor of Science Field of Study Science related discipline or relevant experience in the field - Preferred

Skills:

• Good working knowledge on Validation deliverables and Data Integrity principles.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors
• Strong written and verbal communication skills
• Ability to work in MS Project, Word, Excel, PowerPoint