location_0_addressRegionName

location_0_addressCountryName

ONSITE

TEMPORARY

FULL_TIME

CONTRACTOR

jobPosting hiringOrganization as json hashed.

ADAPTED_NOW

UNKNOWN

Process Engineer

eir evo talent are currently partnering with a leading BioPharma organisation in Waterford, in the search for a dynamic Process Engineer to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes. If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, eir evo and our clients, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent and eir evo

KBSkills

ACTIVE

eir evo talent are currently partnering with a leading BioPharma organisation in Waterford, in the search for a dynamic Process Engineer to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes. In this role, you will be essential to the production of monoclonal antibody (mAb) products, technology transfer, and capacity expansion. Join a collaborative and high-performing engineering team working in a cutting-edge sterile manufacturing environment. Key Responsibilities: <ul><li>Process Development and Optimization: <ul><li>Filter test development and optimization of fill weight cycles</li><li>Cleaning verification to ensure high operational hygiene standards</li><li>Lead technical investigations and implement corrective actions for process-related issues</li></ul></li><li>Documentation and Compliance: <ul><li>Develop and execute key process documents including protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs)</li><li>Author operational control strategy documents and facilitate operator training</li></ul></li><li>Project Management and Coordination: <ul><li>Manage deliverables to meet project timelines and budgets</li><li>Generate detailed schedules for production activities and project planning</li></ul></li><li>Operational and Vendor Support: <ul><li>Support syringe filling processes involving critical equipment such as debaggers, Ebeam, delid/deline systems, isolators, and syringe filling machines</li><li>Liaise with material/component vendors to ensure proper integration and execution of projects</li></ul></li><li>Safety and Compliance: <ul><li>Ensure compliance with Good Manufacturing Practices (cGMP) and safety standards</li><li>Participate in regulatory and safety audits and maintain an audit-ready work environment</li></ul></li></ul>What You’ll Bring: <ul><li>Educational Requirements: <ul><li>Honours degree in an Engineering discipline</li></ul></li><li>Experience and Skills: <ul><li>3+ years of relevant experience in a regulated GMP environment</li><li>Strong problem-solving and troubleshooting abilities</li><li>Prior experience in sterile manufacturing and syringe filling is an advantage</li><li>Experience in new product introductions or technology transfers is highly beneficial</li></ul></li><li>Key Attributes: <ul><li>Strong project management and communication skills</li><li>Ability to collaborate across departments and with external vendors</li><li>A proactive, innovative approach to problem-solving</li></ul></li></ul>Additional Requirements: <ul><li>Willingness to travel as needed to vendor or client sites</li><li>Support site performance goals related to Safety, Quality, Delivery, Cost, and Innovation (SQDCI)</li></ul> Ref: EET6719    —oOo—   Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply.   If you are interested in applying for this role, please do so via the relevant link. If you would like to discuss this role in confidence, please contact Harleen Tora   eir evo talent, eir evo and our clients are equal opportunity employers who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent, eir evo and our clients apply all relevant Data Protection laws when processing your Personal Data.   If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, eir evo and our clients, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent and eir evo

eirevo talent

Antibodies

Budgeting

Communication Skills

Continuous Improvement

Corrective Action

Current Good Manufacturing Practice (cGMP)

Data Processing

Delivery Management

Document Management

Documentation

Failure Mode and Effects Analysis (FMEA)

GMP (Good Manufacturing Practices)

Identify Issues

Information/Data Security (InfoSec)

Maintain Compliance

Manufacturing

Operational Control

Operational Strategy

Operational Support

Problem Solving Skills

Process Development

Process Engineering

Process Improvement

Product/Service Launch

Production Schedule

Project Planning

Project/Program Coordination

Project/Program Management

Regulations

Safety Compliance

Safety Standards

Safety/Work Safety

Strategic Planning

Team Player

Technical Leadership

Test Plan/Schedule

Time Management

Willing to Travel

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