Join a dynamic and innovative pharmaceutical Contract Development and Manufacturing Organization at the forefront of advancing healthcare solutions. I am working with an independant family-owned internationall group of companies, whom from the beginning have set themselves above and apart through their innovative technological and productive capabilities. They have reached a top spot in the world market as an integrated CDMO dedicated to helping pharmaceutical customers bring new off-patent drugs to market.
Their people are the main asset for thier continued success, and have been recognised as a top employer!
Working with my client means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
To be responsible for the management of Process and/or Production works/projects assigned to the role on site. Active participation on new projects, technical transfers from other sites, development in scale up and process improvements to established processes.
- Implement all Process/Production related projects within area of work in compliance with all relevant legislation and regulatory standards including HSE and Quality, and in accordance with the Project Engineering department ways of work.
- Participate in / lead technical transfer or process improvement projects for established process utilizing best available technology, practices and tool as appropriate at all times. These include the use of Lean Manufacturing Techniques, Risk Assessment Technology, Quality by Design, etc.
- Ensure all project risk assessments are carried out in a compliant manner in line with established SOP’s and policies.
- Responsible for preparation and review of /process engineering documentation including project plans and cost proposals, validation plans and execution of validation activities in relation to projects, preparation of validation reports, etc., correctly in a timely manner, while liaising with the Quality Department as required.
- Responsible for on-time project delivery, projects delivery within budget, maintenance of validation status for all project related equipment to the required regulatory standards.
- Investigate and document process/production and project related deviations, planned deviations, out of specification results and implementation of agreed corrective actions as appropriate.
- Initiate, document, and process change controls for project process/engineering related matters as appropriate.
- Present a written monthly report to the Manufacturing Director providing details on agreed KPI’s and metrics
- + additional responsibilities if taking on a more senior role.
- BSc / BEng, MSc / MEng, PhD in chemical engineering or equivalent.
- Min 3-5 years’ experience working within the pharmaceutical industry.
- Tech transfer and start-up experience of multiple projects and product from early-stage development to commercial scale.
- Good capacity for the execution and coordination of all Production activities.
- Experience in equipment and technology design, selection, testing.
- Experience in technical manufacturing support.
- Result driven, team player, able to deal with multiple projects/tasks.
- Strong problem solving skills and solution focused
- Good sense of management and leadership.
- Experience in cGMP's and HSEE rules.
- Ability to interact with and be part of multi-disciplinary teams.