Job ID: JOB-12018
The Validation Department is responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at the Mayo manufacturing site. The Department is also responsible for the revalidation of critical systems & processes. The Validation Engineer is responsible for the qualification of equipment systems and processes as per the site mater plan.
- Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner. To ensure all validation requirements are met for any new process, equipment or change to existing processes or equipment. To actively work on validation projects, being the departmental point person, and completing all associated project documentation in line with current corporate and regulatory expectations. To ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorized and filed in a timely and organized fashion. To work with the other validation engineers to achieve compliance by coordinating each validation project assigned.(60%)
- Ensure timely review of validation documentation and data generated within the team & ensuring all supporting data and packages are presented in the required format(15%)
- Keep abrest of current and changing regulatory guidances for the relevant areas of validation that applies. Provide support for audit preparation, direct audit interaction and involvement in audit responses.(10%)
- Participate in risk assessment process for all business units & Participate in design review process for all business units.(5%)
- Support and comply with internal EHS requirements, procedures and policies. Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards. Attend Departmental and OPEX meetings and participation in Quality and Safety Initiatives.(5%)
- Provide support for audit preparation, direct audit interaction and involvement in audit response. Participation in site internal and external audit program (to include periodic review). (5%)
- Bachelor’s Degree in science based or engineering discipline
- Minimum 5 years experience in the area of validation / similar role
- Ability to articulate clearly when dealing with internal and external bodies.
- Excellent conflict handling skills
- Good written and oral communication skills and ability to communicate to all levels.
- Excellent problem solving skills, time management & project management skills.
- Expertise in the relevant subject matter areas – example Equiment Validation, Cleaning Validations, CSV, Aseptics (Sterilisation Validation), Process Validation, Facility Validation, Automation etc.
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