Job Description
My client a leading Multinational Healthcare Manufacturing company now require a Project Manager to join their expanding team.
The Process Engineer is responsible for the introduction of new equipment and processes and to perform technical development of existing processes.
This is a permanent role based in Dublin and will report to the Project Manager.
Responsibilities of Process Engineer:
? Leading and Managing projects for the introduction of new products, equipment and processes to meet all safety, quality, regulatory and operational requirements.
? Leading cross functional teams as part of project planning and deployment including collaboration with Quality, Safety, Regulatory Affairs, Operations, Facilities and Engineering, Supply Chain and Finance, Project scoping and gap analysis.
? Process mapping and gap analysis.
? Equipment specification/design/procurement/installation and validation.
? Project planning and execution including scheduling, task management, milestone planning and reporting.
? Optimisation of existing processes to achieve product output targets.
? Co-ordinating changes using the clients approved change control procedure to ensure that cGMP is adhered to.
? Generation, review and approval of project documentation (Scope, User Requirement Specifications etc), trial reports and Standard Operating Procedures.
? Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc).
? To ensure that all new equipment is bought in accordance with the EEM (Early Equipment Management) policy.
? To provide technical support to system end users of new and existing equipment including but not limited to troubleshooting technical issues and assisting with process investigations.
? Involvement in Continuous Improvement activities including but not limited TPM and six-sigma.
? To facilitate and participate in meetings and workshops as part of Continuous Improvement activities.
? To develop user materials (e.g. SOPs + training aids) and provide training on new equipment/process functionality. Perform technical review of updates to Standard Operating Procedures (SOPs) related to the equipment/process.
? To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
? To record any deviations relating to the role out of projects, that you are responsible for, through the plant Process Deviation System.
Requirements of Process Engineer:
? Bachelor Degree in Engineering.
? A minimum of 3-4 years' experience in a similar role and industry (Pharma/Biotech).
? The ability to organize, plan and execute multiple tasks to tight schedules.
? Proven track record of project based activities in the pharmaceutical industry.
? Pharmaceutical Manufacturing Process understanding and experience e.g. dry blending, compression, coating, granulation (wet and dry).
? Experience with process/packaging equipment procurement.
Follow us on Twitter, Facebook and LinkedIn
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / johnr@rftgroup.ie / 01 2302400