Process & Validation Engineer

Process \& Validation Engineer

Department: Quality\& Validation

Reports to: Quality \& Validation Manager

RESPONSIBILITIES:

• Process improvement and troubleshooting of Aseptic \& Containment Isolators


• Perform process and functional testing of Aseptic \& Containment Isolators


• Participate in the design transfer of new products from R\&D into production.


• Execution of FAT/SAT/VHP Cycle Development Protocols in house and at client sites.


• Creating technical documents and testing procedures.


• Process validation and develop process improvements \- Increase process efficiencies.


• Work as part of a cross functional project team.


• Plan and design testing procedures for Isolators and other pharmaceutical equipment.


• Support the Sales team via on customer queries and machine performance.

• Technically minded individual with strong reasoning/analytical skills including the ability to, support and prioritize projects and adapt to shifting priorities


• Working knowledge of Risk Management and validation principles


• Ability to comprehend technical information related to equipment, processes, and regulatory expectations


• Demonstrates exceptional project management and organisational skills, with the ability to prioritize and manage multiple tasks effectively.


• Expert in time management, consistently meeting deadlines without compromising quality.


• Able to work independently, in addition to participation in multi\-disciplinary project teams.

• Minimum of Bachelors degree (or equivalent) in an Engineering/Science related discipline.


• 2\-3 years experience in medical device/pharmaceutical/ manufacturing/ Process Development area.


• Knowledge of PLC programming software (Tia Portal/Studio 5000\) a bonus but not required.

Internal

· Mechanical Design Team

· Automation Team

· R\+D team

· Procurement/Finance

· Document Control

External

· End User Clients

· Engineering Consultancies

· Suppliers (including approval process of new suppliers)

JOB LOCATION

• This role is primarily located at the ProSys Group offices in Carrigtwohill, Co. Cork. An ability to travel (up to 30%)

Work authorisation:

• Ireland (required)

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