Senior validation engineer

• Multinational manufacturer of bespoke sterile products and treatments

About the company Our Napier and Christchurch based client is an innovative manufacturer of bespoke sterile health products and treatments. With a stable workforce and highly experienced leadership team, this organisation provides both job security and proactive support for new people joining. Due to sustained demand for their products, the business has acquired a new site and is going through a growth phase. This means they are needing an experienced Validation Manager / Senior Validation Engineer to ensure their manufacturing and support systems are validated to ensure high product quality and compliance to regulatory markets. About the role Reporting to the Director of Quality, this is a lead validation role and is responsible for overseeing all site process, equipment, and facility validation. This includes all current routine validation and management of the VMP, plus taking a leading role in validation of new equipment, processes and facilities as they are introduced to the site. This is a full time (40 hours/week) and a permanent position working Monday to Friday with occasional need to be flexible on working hours to accommodate the validation needs of the facility. Frequent travel between their Napier and Christchurch sites will also be required. Duties/responsibilities

• Strategic development of validation and compliance within the business
• Ensure all validation requirements within the business are met and maintained
• Production / Aseptic processing support
• Develop, coordinate and implement validation documents and procedures, and maintain these on a current database.
• Liaise with other departments, supporting their process and validation requirements

Skills/experience

• Tertiary or trade qualification in a relevant engineering or scientific field
• 5+ years pharmaceutical manufacturing industry experience
• Experience in process validation including IQ, OQ, PQ protocol generation and execution to a developed level
• Broader QA and GMP experience within a pharmaceutical (or equivalent) environment

Culture Our client has a supportive team culture which sees very few of its team leave for new pastures. They encourage their staff to grow within the business supporting personal development and look at long term succession-planning when considering applicants.

• Growth within the business
• Happy and supportive working environment
• Flexibility for the incumbent to be based in either Napier or Christchurch

How to apply For a confidential enquiry or to apply for this position please click on the relevant APPLY button, alternatively contact Maya Carpenter-Salvador on maya@trs.co.nz #J-18808-Ljbffr