Excellent opportunity to develop professional skills within a leading company.
The successful candidate will play an active role on new and existing projects, technical transfers from other sites, development in scale up and improvements to established processes. They will also be responsible for proposing, evaluating and implementing changes to the processes and procedures related with projects under his/her evaluation.
This is an excellent role for someone with some pharmaceutical experience working as a Process Engineer looking to enhance their career.
In order to be thrive in this role the Process Engineer must be able to:
- To communicate with clients when appropriate.
- To prepare and submit for approval: process documentation, procedures, instructions, reports and other relevant documentation related with the regular area activity.
- To train staff on her/his areas of expertise.
Main activities and repsonsibilities include:
- Implementing 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.
- Other duties as required by the Manufacturing Director, which is in keeping with the nature of the role.
Qualification and Skill requirements include:
- BSc / BEng, Msc / MEng, Phd in chemical engineering or equivalent.
- Good capacity for the execution and coordination of all Production activities.
- Result driven, team player, able to deal with multiple projects/tasks.
- Knows how to overcome problems with staff.
- Good sense of management and leadership.
- Experience in cGMP's and HSEE rules.
- Experience working within the pharmaceutical industry.
- Experience in equipment and technology design, selection, testing and procurement.
- Experience in technical manufacturing support.
- Tech transfer, capital project support, and start-up experience of multiple projects and product from early stage development to commercial scale.
- Experience in Production operations, trouble shooting.
- Current knowledge of cGMP and HSE regulatory requirements.
- Excellent written and verbal communication skills.
- Excellent analytical skills.
- Ability to interact with and be part of multi disciplinary teams.
- Creativity, organization and discipline.
- Availability and ability to take ownership.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.