Manufacturing Shift Leader

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As part of the ongoing project in Livingston we are now seeking interest for key roles within the Manufacturing team and are seeking interest in our Manufacturing Shift Leader Positions.

Job Summary

To co-ordinate the execution of manufacturing steps according to defined procedures and protocols in line with cGMP work practices and quality standards. This role is dedicated to the management of production, production resources within a shift and will review, organise and where necessary develop systems / processes in order to achieve:

• Effective control of all production activities
• Effective management of a small team of supervisors
• Effective planning and co-ordination of activities within manufacturing
• Effective planning and co-ordination with support functions

Responsibilities

• On a day to day basis coordinating all supervisors and senior technicians to co-ordinate production plans within a shift in order to deliver product to appropriate time, quality and costs
• To make sure that all production steps defined by SOPs, production records and protocols are being executed in compliance with cGMP standards
• Ensuring manufacturing rooms are prepared ready for activities, pick lists submitted in time to ensure raw materials available. PPRs and labels available in room prior to activities commencing
• Ensure that there are clear systems for shift handovers
• Working in cleanrooms / supervising activities as required
• Ensuring that all paperwork has been completed for room activities prior to staff leaving room
• To oversee that best cGMP work practices and techniques to produce product within specification are being applied, ensuring that when in operation equipment, facilities and materials used in the area of responsibility comply with defined standards
• Ensure that all production supervisors and staff are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times
• Ensure PPRs are kept up to date to reflect expected manufacturing techniques to remove any ambiguity in instructions
• Responsibility for coordination and planning of cellbank activities
• Responsibility for coordination and planning FBS qualification activities
• Responsibility for coordination and planning virus seedbank manufacture
• Responsibility to motivate supervisors and their staff to help when there are additional pressures
• Promptly reporting any issues requiring engineering intervention
• Develop and ensure delivery of a training plan to build on the skills of current production personnel and allow rapid contribution from new personnel
• Be responsible for the development, collating and reporting of key quality and business metrics and use such metrics to drive a culture of continuous improvement
• Identifying opportunities for improvements
• Responsibility for ensuring that any deviations, change controls or CAPAs related to materials, facilities, processes or procedures within your shift are escalated and addressed within agreed timelines. Reviewing and approving QMS items, ensuring that they are completed to a high standard
• Liaise with all manufacturing staff, ensuring that all direct and indirect production areas are clean, tidy and well organised and in a state of continuous inspection readiness
• Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
• Completion of Goals and Objectives, 121s, mid year reviews and end of year reviews for staff, within expected timelines
• To undertake any other duties as requested by line manager in accordance with company requirements

Job Requirements

Experience:

Educated to degree level in relevant qualification, or equivalent experience

Minimum of 5 years relevant production experience at senior level

Proven track record of supervising a team of 4 or more

Experience in vaccine production / commercial

Animal cell culture experience

Cell bank experience

Required Skills:

Flexibility, as there may be a variance in daily schedules from time to time (shift / weekend)

Good understanding and working knowledge of the Pharma industry

Maintenance of a professional attitude

Confidence in dealing with difficult staff

Encouraging and developing staff

Ability to recognise staff behaviours, rewarding good behaviours and swiftly dealing with any issues

Ability to develop a team culture