Department: Engineering
Location: Cork
Contract Type: 6-month Contract
Job Summary:
We are seeking a Quality Project Engineer to support our client's engineering department. In this role, you will play a key part in New Product Introduction (NPI) and provide crucial validation support for equipment and processes. The ideal candidate will have a strong Quality background, a solid understanding of GMP, and a passion for ensuring product quality and process efficiency.
Responsibilities:
- Contribute to New Product Introduction (NPI) development projects.
- Provide project validation support, including conducting Risk Assessments (FMEA), defining requirements, and managing qualifications for new equipment (URS/IQ/OQ/PQ/PV).
- Ensure all activities comply with GMP and company procedures.
- Author project validation master plans, SOPs, and other relevant documentation.
- Author validation protocols and final reports, execute validation studies, and analyze validation data.
- Resolve technical issues encountered during study execution.
- Work collaboratively with cross-functional teams, including engineering, production, quality assurance, supply chain, and external suppliers, maintaining excellent rapport with internal and external customers.
- Identify process bottlenecks and develop solutions to resolve them.
- Provide hands-on support for product and process development.
- Provide hands-on support for maintaining and fixing process equipment.
Qualifications:
- Degree: Level 8 Bachelor's degree in a related science OR engineering discipline (Mechanical, Manufacturing, etc.).
- Experience: 2-5 years of relevant experience in a manufacturing environment. Experience in automated manufacturing is a plus.
- Equipment/Cleaning/Process Qualification/Validation: Desired experience in equipment qualification and validation.
Skills and Abilities:
- Strong understanding of validation principles and methodologies.
- Proficiency in GMP and regulatory requirements.
- Excellent technical writing and documentation skills.
- Ability to perform risk assessments (FMEA).
- Solid analytical and problem-solving skills.
- Ability to work independently with moderate direction and demonstrate knowledge in the field.
- Strong collaboration and communication skills to work effectively with cross-functional teams.
- Ability to identify and resolve process bottlenecks.
- Hands-on approach to problem-solving and equipment support.
Benefits:
- Competitive rate
- Contract position with the possibility of extension
- Opportunity to work with a dynamic and growing company
- Collaborative and supportive work environment
- Professional development opportunities
