An amazing opportunity has arisen for a Senior Process Validation Engineer on a contract basis with Crest Solutions based on client site.
WHAT WE DO:
Crest Solutions are an Engineering & Software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.
JOB PURPOSE:
The primary purpose of this job is to support major Manufacturing Engineering Projects.
The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are achieved.
KEY COMPETENCIES REQUIRED (TO PERFORM THE JOB TO ACCEPTABLE STANDARD)
• Excellent communication skills (written and oral).
• Problem solving skills – to assist in maintaining project progress and on design issues.
• Statistical analysis & experimental design – Proficient in Six Sigma techniques such as ANOVA (analysis of variance), DOE (design of experiments), capability etc
• Decision Making – required to make decisions on technical issues.
• Degree of responsibility – must be capable of taking direction and taking responsibility and ownership for systems.
• Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem-solving skills.
• Flexible work ethic.
• Strong influencing skills.
• Excellent planning & organisation skills.
• Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.
• Continuous Improvement Focus
• Degree qualified in a relevant Engineering / Science discipline, with 3+ years relevant experience.
• Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
• Six Sigma Black Belt certified is preferred.
• Experience in Statistical analysis & experimental design is essential.
• Proficient in Minitab
• Proficient technical report writing skills.
• Experience in regulated industry, FDA, ISO, etc.
• Experience in medical device industry is preferred
• Proficient in current Good Manufacturing, Engineering, Practices etc (GxP).
• Full knowledge of industry practices.
• Strong written, verbal, and interpersonal communication skills are required.
• Proficient in Microsoft Office applications.
• Demonstrated leadership skills and the ability to make effective decisions.
