Job Type: Contract
Job ID: JO-2301-31821
Consultant: Karen McHugh
Are you an Automation Project Manager with 7+ years Pharmaceutical automation/IT knowledge and equipment procurement and validation experience?
If interested in this role, call Karen on +353 1 7978720 to discuss or forward your CV to firstname.lastname@example.org for review
Automation Project Manager - Pharma - Kildare
Our Client is one of Ireland's leading engineering consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
The Project Manager 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 including but not limited to; introduction of new projects, troubleshooting issues, equipment upgrade and procurement in the manufacturing/packaging and process activities.
This is a site projects based role.
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.
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
To ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
Generation/Review of trial reports and Standard Operating Procedures.
Equipment specification/design/procurement/installation and validation.
Detailed design (FS/HDS/SDS review)
Production/Implementation of Validation Project Plan
Managing and executing equipment trials and validation.
Scope development and approval
Cost estimating and funding request
Experience developing, coordinating and delivering project schedules and budgets
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)
Reviewing & approving RAMS
To adhere fully to all safety policies, procedures and regulations.
B.Eng / B.Sc in Computer Science / Mechatronics or appropriate science/engineering discipline.
5-7 Years Post Qualification recent relevant experience in an engineering/projects role in the Pharma/Biotech/Chemical industry.
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
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.
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.
Contract rates of €55 - €65 per hour, depending on role
18-month contract minimum
Karen McHugh is the consultant managing this position.
If you are an Automation Engineer interested in roles based in Dublin, you can contact Karen by e-mail email@example.com or phone +353-1-7978720 for a confidential chat.
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