Equipment Validation Specialist

Job Title: Equipment Validation Specialist

Location: Portsmouth, NH - 03801

Duration: 9 Months

Job Type: Contract

Work Type: Onsite

Pay Rate: $60 to $65/hr

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Summary

• Equipment Validation Specialist role ensures 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 Responsibilities:

• 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 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), 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.

Required Qualifications:

• Bachelors Degree in a Science related discipline or relevant experience in the field
• 5 to 10 years of experience in Manufacturing, QC, Validation
• Advanced technical knowledge of Quality control and manufacturing operations.
• 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.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• 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
• Must comply with safety policies of the company and site.
• 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.
• Adherence to cGMPs is required at all times during the manufacture of APIs.
• All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions

TekWissen® Group is an equal opportunity employer supporting workforce diversity.