Senior Validation Specialist
Galway
Contract
POSITION PURPOSE
The Senior Validation Specialist will take the lead and project manage validation/qualifications activities. The Senior Validation Specialist assumes responsibility for overseeing and where required execution of Validation/Qualification activities. This will require the individual to liaise with Engineering, Operational, QA/QC, Microbiology, EHS, and regulatory departments along with third party suppliers, and vendors to deliver the required objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Must possess knowledge of pharmaceutical and medical device regulatory requirement for FDA and HPRA regulated environments.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's Degree in a Technical, Science, Production or Process discipline and a minimum of six (6)years’ experience in a validation role within the Pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.
The Senior Validation Specialist will take the lead and project manage validation/qualifications activities. The Senior Validation Specialist assumes responsibility for overseeing and where required execution of Validation/Qualification activities. This will require the individual to liaise with Engineering, Operational, QA/QC, Microbiology, EHS, and regulatory departments along with third party suppliers, and vendors to deliver the required objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Plan, lead and execute complex projects from initial concept to final validation.
- Act as the Validation Lead on complex validation projects.
- Review and approve validation protocols and reports
- Manage validation process through New Product Introduction Process (NPI) as required.
- Provide guidance and support and technical expertise to the validation group in allocated projects as required.
- Ensure that all validation activities are adhered to and closed as per the stage and gate process for site projects.
- Coordinate team activities to ensure schedule adherence, site permanent inspection readiness and continued site compliance.
- Present validation systems at internal and external audits and support quality assurance programmes in conjunction with the Validation Manager.
- Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
Must possess knowledge of pharmaceutical and medical device regulatory requirement for FDA and HPRA regulated environments.
- Knowledge of Pharma/Medical product manufacturing, especially sterilisation processes and/or filling operations.
- Experience in process, software, filling and sterilisation process validation.
- Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.
- Experience with statistical software packages.
- Ability to understand manufacturing processes.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's Degree in a Technical, Science, Production or Process discipline and a minimum of six (6)years’ experience in a validation role within the Pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.
