Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
We are looking for a Validation Engineer to join our Technical Operations team in Manorhamilton Road Sligo. This position reports to the Validations Team Lead. This role provides the successful candidate with the opportunity to get exposure to a broad range of validation activities on our site. You will be responsible for co-ordinating the development and maintenance of the companys validation program in compliance with all applicable regulatory and company requirements.
Responsibilities:
- Co-ordinate implement and participate in the site Validation Program.
- Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
- Co-ordinate / direction and participate in the validation of site equipment facilities utilities processes and software in compliance with company policies FDA European cGMP and GAMP standards.
- Generate/maintain Validation Master Plans.
- Generate /maintain Project Validation Plans.
- Generate validation plans write protocols and final reports to cGMP standard.
- Review / approve of protocols and final reports as required.
- Manage validation change control process.
- Adhere to and support all EHS & E standards procedures and policies.
Qualifications :
- 3rd level qualification in a relevant engineering or scientific discipline.
- A minimum of 2 years experience in a cGMP regulated pharmaceutical manufacturing environment.
- High level of attention to detail and mental concentration to ensure accuracy and compliance.
- Excellent communications skills with the ability to write protocols and reports.
- Proven problem-solving skills and the ability to adapt to new regulatory requirements.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
