Senior Validation Engineer

Collins McNicholas Recruitment; Galway City; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading company in the medical device sector is seeking a Senior Validation Engineer for a 6-month contracting opportunity in Galway. The successful candidate will oversee validation activities for a new product, adhering to FDA and GMP standards. This role requires a Bachelor's degree in a relevant field and substantial industry experience, along with strong communication and analytical skills.

Qualifications

• 5+ years’ experience in the medical device or pharmaceutical industry.
• Proven design and execution of process and test method validations.
• Knowledge of ISO 13485 and 21 CFR 820 requirements.

Responsibilities

• Develop and approve validation documentation including protocols and reports.
• Perform and oversee process and test method validation activities.
• Communicate validation results and progress to management.

Skills

Analytical skills

Interpersonal relationship skills

Organisational skills

Communication skills

Education

Bachelor's degree in engineering, technology or scientific discipline

Job description

Senior Validation Engineer – Contracting Opportunity!

We are supporting an innovative early stage medical device company who are developing cutting-edge technology and are getting ready for FDA approval at their manufacturing site in Galway.

To support development and manufacturing efforts, they require a Senior Validation Engineer on an initial 6-month contract to cover the validation activities with respect to the testing and manufacture of this new Medical Device product.

Role/ Responsibilities:

• Develop, and/or approve, validation documentation, including protocol, records, and reports.

• Performing and overseeing process and test method validation activities within the project.

• Execution of process and test method validation activities in association with Operations, Quality Assurance and R&D teams.

• Ensure that all validation activities are carried out and reported in a timely manner and in accordance with the project plan.

• Ensuring compliance with current Good Manufacturing Practices (GMPs)and 21 CFR 820 requirements in all validation aspects.

• Communicate with all functional groups to ensure awareness of validation requirements.

• Investigate and trouble-shoot validation problems which may occur and determine solutions.

• Communication of validation results and progress to management.

• As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.

Qualifications & Experience:

• Bachelors in an engineering, technology or scientific discipline required with 5+ years’ experience in the medical device or pharmaceutical industry.

• Prior experience in the design and execution of process and test method validations.

• Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.

• Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.

• Ability to work as part of a team and meet targets/goals efficiently.

• Demonstrated organisational, management and communication skills.

• Good interpersonal & communication skills essential.

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For a confidential discussion and more information on rates, please contact Davin Ferguson

[e-mail]

071 91 40251