Job Type: Contract
Job ID: JO-2109-27460
Consultant: Karen McHugh
Are you a Project Process Engineer / Project Manager with 8+ years experience in both quality and analytical development?
Has your work has included testing, scheduling quality, stability data review, Release material on gLIMS, batch dispositioning, skilled in SAP.?
If interested in this role, call Karen on +353 1 7978720 to discuss or forward your CV to firstname.lastname@example.org for review
Project Automation Engineer / Project Manager - Pharma Projects - Dublin
Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors with offices in Cork and Dublin.
They have a large number of Biotech projects in the pipeline and will be looking for process engineers to get involved in these projects.
The Automation Projects Engineer 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 Automation Engineer will report directly to the Programme Manager on all aspects of the role including but not limited to; introduction of new projects, troubleshooting issues, equipment upgrade and procurement in the manufacturing/packaging and process validation 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 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
Good computer based skills, including Windows knowledge and network architectures, database knowledge beneficial
Knowledge of PLC and SCADA systems
Knowledge of SQL & Oracle Database systems
Knowledge of MES, Batch & Historian systems
Knowledge of Enterprise IT Applications Including associated printing and mobile handheld devices
Knowledge of Network Infrastructure
Knowledge of Computer System Validation (CSV) and regulations including, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
Scope development and approval
Generation/Review of trial reports and Standard Operating Procedures.
Equipment specification/design/procurement/installation and validation.
Detailed design (FS/HDS/SDS review)
To ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
Production/Implementation of Validation Project Plan
Managing and executing equipment trials and validation.
Automation development (as part of technical transfer), troubleshooting and optimisation.
Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.
Ensures all activities, equipment and facilities comply with site cGMP, Health, Safety and Environmental policies
PROJECT MANAGEMENT SKILLS
The ability to organise, plan and execute multiple tasks to tight schedules
Experience with equipment procurement.
Experience developing project schedules and budgets
Flexibility and ability to adapt to changing priorities is required.
Ability to document own work clearly and precisely
Monitor activity progress for the project in line with the project objectives, deliverables and timelines and report potential delays including mitigation recommendations
Manage the project Risk Log ensuring all identified risks have been mitigated
Provide project reports on a regular basis for effective communication
Provide support for product costing and financial assessment of the project
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.
Project management and co-ordination including planning, scheduling, task management and delegation, milestone planning, communication and reporting.
Delivering projects on time and on budget.
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.
Scope development and approval
Project schedule development and coordination
Scope change management
Cost estimating and funding request
Tender package generation
Executing ERES assessments
Executing, and reviewing commissioning protocols
Executing, and reviewing validation protocols
Validation summary reports
Standard Operating Procedures & Work Instructions
Co-ordinating changes using the Client approved change control procedure to ensure that cGMP is adhered to.
To record any deviations relating to the role out of projects, that you are responsible for, through the plant Deviation System.
Experience with safety procedures (RAMS, permits, SPAs, etc)
Health & Safety Plans
Reviewing & approving RAMS
To adhere fully to all safety policies, procedures and regulations.
B.Eng 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 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 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 related to the role.
Contract rates of €60 - €80 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 at email@example.com or phone +353-1-7978720 for a confidential chat.
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