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.
ROLE REQUIREMENTS:
- 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.
EDUCATION:
- 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.
KEY INTERACTIONS & STAKEHOLDERS
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%)
Job Types: Full-time, Permanent
Work authorisation:
Work Location: In person
