Validation Specialist II

Description

Work Schedule : 9-5, Mon-Fri, On-site

• BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience.
• Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.

Areas of experience:

• Shipping Validation.
• This is a program lead role and will include status tracking of all projects, periodic reporting of the status of all projects to leadership, supporting design of transport qualification strategies, reviewing and
• approving transport validation deliverables and accountability for on-time delivery of all transport qualification milestones.
• Well-developed communication skills, both verbal and written..

Years of Experience: 3 - 6 Years

This project encompasses temporary, full-time support to be the lead point of contact for the shipping validation program during a leave period for the primary program owner. This will include tracking the status of all projects, the periodic reporting of the status of all projects to management, supporting design of transport qualification strategies, reviewing and approving transport validation deliverables and accountability for on-time delivery of transport qualification deliverables for a period of 6 months.

• Possibility of Extension
• No exposure to chemicals
• Free Parking onsite
• Local candidates only
• Role will report to 2 sites, 11 Forbes Northborough, MA as needed.
• Must have reliable transportation.
• Lifting, temperature-controlled environments – cold room at times.
• PPE is required, glasses, vest, personal protective equipment (PPE), protocol generation, execution and closure

Must have Skills:

• Bachelor’s degree in engineering (BSc/BEng) or related scientific discipline, or an equivalent combination of education and experience.
• 3–6 years of experience within the pharmaceutical/biopharmaceutical industry - related to shipping validation.
• Familiar life cycle documentation
• IQ/OQ/PQ installation qualification, operational and performance qualification
• Demonstrated expertise in shipping/transport validation processes
• Experience with logistics, customs, international shipments/ cold chain experience
• Risk assessment, protocol generation, execution and closure.

Nice to Have Skills:

• Experience KNEAT (computer system a plus)