Automation – IT Project Manager (Pharmaceutical Automation) Based with a Pharmaceutical Production end user client.
Suitable Candidates will have: 3rd level degree in Computer Science / Mechatronics or appropriate science/engineering discipline plus 5-7 Years Post Qualification recent relevant experience in an engineering/projects role in the Pharmaceutical/Biotech/Chemical industry including:
A proven track record in automation/IT project management for support and improvement projects.
Experience with various technologies.
Proven track record of project based activities in the pharmaceutical industry.
Project Management experience
JOB PURPOSE This is a crucial role within the Engineering department to ensure the introduction of new equipment and processes and to perform technical development of existing systems.
Working in a highly regulated and cGMP environment within the pharmaceutical industry, the Project IT/Automation Engineer role will include but not limited to; introduction of new projects, troubleshooting issues, equipment upgrade and procurement in the manufacturing/packaging and process activities.
The successful candidate must have strong leadership and planning qualities, be adaptable to change and be comfortable leading cross functional teams delivering to strict deadlines and budgets. Pharmaceutical automation/IT knowledge and equipment procurement and validation experience is required.
- Good computer based skills, including Windows knowledge and network architectures, database knowledge beneficial.
- Knowledge of Network Infrastructure and S95 Standard.
- Knowledge of Enterprise IT Applications
- Knowledge of PLC and SCADA systems.
- Knowledge of MES, Batch & Historian systems and S88 Standard .
- Knowledge of Computer System Validation (CSV) and regulations including, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- To ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
- Generation/Review of trial reports and Standard Operating Procedures.
- URS generation.
- Equipment specification/design/procurement/installation and validation.
- Detailed design (FS/HDS/SDS review).
- Production/Implementation of Validation Project Plan.
Project Management Skills
- Scope development and approval.
- Cost estimating and funding request.
- Experience developing, coordinating and delivering project schedules and budgets.
- Vendor management.
- Leading and Managing projects for the introduction of new Solid Oral Dose 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 supporting departments such as Production/Operations, Quality, Safety, Regulatory Affairs, Facilities and Engineering, Supply Chain and Finance, Project scoping and gap analysis.
- Standard Operating Procedures & Work Instructions.
- To record any deviations relating to the role out of projects, that you are responsible for, through the plant Deviation System.
- Progress reporting, including Project Schedule and Financials
- Experience with safety procedures (RAMS, permits, SPAs, etc).
- Health & Safety Plans.
- Reviewing & approving RAMS.
- To adhere fully to all safety policies, procedures and regulations.
- Good communication and technical writing skills are a must.
- Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
- Good communication skills combined with an imaginative and creative approach to problem solving.
- Demonstrated Analytical and Problem solving skills.
- An ability to work independently.
- Directing of more junior team members.
- To participate in all training and assessment activities.
- To facilitate and participate in meetings and workshops as part of Project and Continuous Improvement activities.
- To perform all activities in accordance with current Good Manufacturing Practice.
- To ensure development occurs of user materials (e.g. SOPs + training aids) and provide training on new equipment/ 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.
- Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ etc).
- 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.
- Ensure smooth transfer of project knowledge and technology from engineering to production.
- Analyse, understand, fault-find and modify automation software.
Terms: Long term contract role up to €65 per hour depending on experince
For further information or to apply contact: Tom Doyle at kppm, P: 086 8205038.
or email firstname.lastname@example.org
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