I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
Connect with me on
Process Engineer
Limerick
C&Q Engineer
Dublin
Project Engineer
Limerick
R&D Engineer
Limerick City
Project Manager
Limerick
QA Manager
Cavan
Project Engineer
Limerick
R&D Manager
Galway
Qualified Person
Waterford
Clinical Research Associate (CRA)
Republic of Ireland
eClinical Project Manager
Republic of Ireland
Senior Planner
Limerick
QP Manager
Dublin
QC Scientist
Limerick
Senior Lab Analyst
Waterford
Process Engineer
Dublin North
Quality Engineer
Limerick
R&D Manager
Limerick
Operations Lead/ Engineer
Republic of Ireland
Project Engineer
Limerick
QA Manager
Dublin
Business Program Lead - Remote
Republic of Ireland
Technical Writer
Limerick
eClinical Project Coordinator
Republic of Ireland
Operations Lead/ Engineer
Republic of Ireland
Head of R&D
Galway
Planner
Limerick
Validation Lead
Limerick
Senior R&D Engineer
Limerick City
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Operations Lead/ Project Engineer


Reference:/RH/0031121 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Project Engineer

Life Science Recruitment are recruiting anOperations Lead/ Project Engineer to join the team with our Pharmaceutical client based inSouth Dublin.

Operations Lead will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects. They will be operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.

Role & Responsibilities:
• Function as the site interface between the Product Delivery Teams (PDT’s), and Manufacturing operations.
• Develop, review and approve generic batch records and parameter value lists across Formulation, Filling and Inspection
• Develop, review and update Production, Engineering, Operating Procedures & training materials
• Assist in providing training on scientific or technical aspects of the process/project
• Evaluate, plan, and implement solutions for process improvement opportunities
• Support scheduling and execution of Characterisation, Engineering and PPQ runs including ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
• Provide troubleshooting support throughout the project and on the floor during execution of activities
• Hold people to account for delivery and behaviours within Product team
• Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
• Partner with Learning & Performance to define training strategy’s for NPI’s and complex projects
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences
• Develop, review and update Protocols for manufacturing activities


Qualifications & Requirements:
• Bachelor’s degree in a science discipline.
• 2+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Project Management and organizational skills, including ability to follow assignments through to completion
• Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
• Negotiation and Influence skills
• Take initiative to identify and drive improvements
• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) and good Presentation skills


For more information contact Ruth Hollandon087 7822198 or [email protected]